Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Resource Profile: M11Report

Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report Version: 1.0.0-ballot2
Standards status: Trial-use Maturity Level: 1 Computable Name: M11Report
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.57

Copyright/Legal: This Profile is developed to support the evolving draft of the M11 Template. The ICH is the copyright holder for the M11 template and has not endorsed or sponsored this Profile.

Profile of Composition for Evidence Based Medicine IG. The M11Report Profile is used for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.

See Understanding the Composition Resource for additional information.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* EvidenceReport A set of resources composed into a single coherent clinical statement with clinical attestation
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension Content/Rules for all slices
.... extension:versionAlgorithm 0..1 Coding How to compare versions
URL: http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
Binding: VersionAlgorithm (extensible)
.... extension:experimental 0..1 boolean For testing purposes, not real usage
URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental
.... extension:description 0..1 markdown Natural language description of the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-description
.... extension:purpose 0..1 markdown Why this artifact is defined
URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose
.... extension:copyright 0..1 markdown Use and/or publishing restrictions
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright
.... extension:copyrightLabel 0..1 string Copyright holder and year(s)
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel
.... extension:approvalDate 0..1 date When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-approvalDate
.... extension:lastReviewDate 0..1 date When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-lastReviewDate
.... extension:effectivePeriod 0..1 Period When the artifact is expected to be used
URL: http://hl7.org/fhir/StructureDefinition/artifact-effectivePeriod
.... extension:additionalLanguage 0..* code The additional language
URL: http://hl7.org/fhir/StructureDefinition/additional-language
Binding: AllLanguages (required): IETF language tag for a human language
.... extension:extendedContactDetail 0..* ExtendedContactDetail Contact details for the publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-extended-contact-detail
.... extension:publicationDate 0..1 date Publication date of Resource
URL: http://hl7.org/fhir/StructureDefinition/artifact-publicationDate
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
.... coding 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 35528-9
..... display 1..1 string Representation defined by the system
Fixed Value: Clinical trial protocol Clinical trial protocol
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
Required Pattern: CeSHarP Report
... date Σ 1..1 dateTime Composition editing time
... author Σ 1..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the composition
... title Σ 1..1 string Human Readable name/title
... Slices for relatesTo 0..* BackboneElement Relationships to other compositions/documents
Slice: Unordered, Open by value:type
.... relatesTo:All Slices Content/Rules for all slices
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:citeAs 0..1 BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: cite-as
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:partOf 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: part-of
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:derivedFrom 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: derived-from
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:specificationOf 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: specification-of
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:dependsOn 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: depends-on
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:supportedWith 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: supported-with
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
... Slices for section C 15..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code.text
Constraints: cmp-1, cmp-2
.... section:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:titlepage SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Title Page
..... entry C 0..* Reference(StudyDesign) A reference to data that supports this section
.... section:summary SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Summary
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:protocolSynopsis S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Synopsis
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:objectivesEndpoints S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Primary and Secondary Objectives and Estimands
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Composition) A reference to data that supports this section
........ section:overallDesign 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Design
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Composition | ResearchStudy) A reference to data that supports this section
........ section:numberOfArms 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:blinding 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:numberOfParticipants 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:duration 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:committees 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:trialSchema S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Schema
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
...... section:scheduleOfActivities S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Schedule of Activities
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
.... section:introduction SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Introduction
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:purposeOfTrial S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Purpose of Trial
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:benefitsAndRisks S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assessment of Risks and Benefits
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:riskSummary 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk Summary and Mitigation Strategy
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:trialIntervention S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Intervention Risks and Mitigations
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:trialProcedures 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Procedure Risks and Mitigations
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:otherRisk 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Other Risks and Mitigations
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:benefitSummary S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Benefit Summary
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:overallBenefitRisk 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Risk-Benefit Assessment
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:estimands SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Objectives and Associated Estimands
..... entry C 0..* Reference(StudyDesign) A reference to data that supports this section
.... section:design SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Design
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:description S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Design
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:stakeholderInput S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Stakeholder Input into Design
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:rationale S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Trial Design
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:endpoints S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Estimand(s)
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:model S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Intervention Model
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:comparator S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Control Type
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:duration S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Duration
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:adaptive S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Adaptive or Novel Trial Design
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:interim S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Interim Analysis
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:otherAspects S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Other Trial Design Aspects
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:trialStoppingRules S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Stopping Rules
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:startEnd S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Start of Trial and End of Trial
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:access S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Access to Trial Intervention After End of Trial
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:population SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Population
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:description S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Population and Rationale
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:inclusionCriteria S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Inclusion Criteria
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:exclusionCriteria S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Exclusion Criteria
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:contraception S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:contraceptionDefinitions S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions Related to Childbearing Potential
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:contraceptionDetails S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception Requirements
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:lifestyle S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Lifestyle Restrictions
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:dietary S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Meals and Dietary Restrictions
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:substances S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:activity S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Activity Restrictions
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:other S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Activity Restrictions
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:screenFailures S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screen Failure and Rescreening
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:intervention SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Intervention and Concomitant Therapy
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 9..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:description S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Investigational Trial Intervention
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
...... section:rationale S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
...... section:dosingAdministration S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Administration
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ActivityDefinition) A reference to data that supports this section
...... section:doseModification S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Dose Modification
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ActivityDefinition) A reference to data that supports this section
...... section:treatmentOfOverdose S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Investigational Trial Intervention Overdose
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ActivityDefinition | PlanDefinition) A reference to data that supports this section
...... section:preparation S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:preparationIntervention S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation of Investigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:storageHandling S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Storage and Handling of Investigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:accountability S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Accountability of Investigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:assignmentAndBlinding S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:assignment S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Assignment to Investigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:randomisation S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Randomisation
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:blinding S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Measures to Maintain Blinding
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:unblinding S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Unblinding at the Site
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:adherence S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Adherence
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:noninvestigationalTherapy S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Non-Investigational Trial Intervention
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:background S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Background Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:rescue S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rescue Therapy
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:other S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Noninvestigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:concomitantTherapy S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Concomitant Therapy
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:prohibited S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prohibited Concomitant Therapy
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:permitted S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permitted Concomitant Therapy
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:dropout SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:discontinuation S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation of Trial Intervention for Individual Participants
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:permanent S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permanent Discontinuation of Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:temporary S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Temporary Discontinuation of Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:rechallenge S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rechallenge
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:withdrawal S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation or Withdrawal from the Trial
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:lostToFollowUp S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Loss to Follow-Up
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:assessments SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 8..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:considerations S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures Considerations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:screeningBaseline S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screening/Baseline Assessments and Procedures
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:efficacy S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Efficacy Assessments and Procedures
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:safety S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Assessments and Procedures
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:physical S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Examination
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:vitals S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Vital Signs
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:ecg S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Electrocardiograms
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:laboratory S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Assessments
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:pregnancy S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy Testing
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:suicidal S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:pharmacokinetics S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacokinetics
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:biomarkers S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Biomarkers
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:genetics S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Genetics and Pharmacogenomics
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:pharmacodynamics S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacodynamic Biomarkers
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:other S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Biomarkers
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:immunogenicity S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Immunogenicity Assessments
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:economics S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Medical Resource Utilisation and Health Economics
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:adverseEvents SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events, Serious Adverse Events, Product Complaints, Pregnancy and Postpartum Information, and Special Safety Situations
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:definitions S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:adverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Adverse Events
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:seriousAdverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Serious Adverse Events
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:productComplaintsDefinitions S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Product Complaints
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:collectionMethods S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing and Procedures for Collection and Reporting
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 5..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:timing 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:procedures 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Collection Procedures
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 5..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:identifying 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Identification
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:intensity 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Severity
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:causality 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Causality
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:recording 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Recording
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:followup 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Follow-up
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:reporting 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Reporting
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:regulatoryRequirements 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory Reporting Requirements
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:specialInterest 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events of Special Interest
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:diseaseRelatedEvents 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:pregnancy S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy and Postpartum Information
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:pregnant S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Who Become Pregnant During the Trial
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:pregnantPartner S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Whose Partners Become Pregnant
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:special S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Special Safety Situations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:statistics SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Considerations
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:considerations S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: General Considerations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:analysisSets S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analysis Sets
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:analysisBaseline S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses of Demographics and Other Baseline Variables
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:analysisPrimaryObjective S 1..* BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Primary Objective(s)
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:analysisPrimaryInstance S 1..* BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:statisticalModel S 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Primary Estimand(s)
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:missingData S 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:sensitvityAnalysis S 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:secondaryAnalysis S 0..* BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Secondary Objective(s)
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:analysisSecondaryInstance S 1..* BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:statisticalModel S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:missingData S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:sensitvityAnalysis S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:exploratoryAnalysis S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Exploratory Objective(s)
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:safetyAnalyses S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Analyses
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:otherAnalyses S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Analyses
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:multiplicity S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Multiplicity Adjustments
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:interimAnalyses S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Interim Analyses
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:sampleSize S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sample Size Determination
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.... section:oversight SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight and Other General Considerations
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 12..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:regulatory S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory and Ethical Considerations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:trialOversight S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:investigatorResponsibilities S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigator Responsibilities
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:sponsorResponsibilities S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sponsor Responsibilities
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:committees S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Committees
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:informedConsent S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent Process
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:assentProcess S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assent Process
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:emergency S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Consent Process
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:rescreening S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Rescreening
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:remainingSamples S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:insurance S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Insurance and Indemnity
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:riskManagement S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk-Based Quality Management
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:dataGovernance S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Governance
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:dataProtection S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Protection
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:sourceData S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Source Data
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:protcolDeviations S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Deviations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:earlySiteClosure S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Early Site Closure
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:decisionRights S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Decision Rights for Site Closure
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:criteria S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Crteria for Early Closure
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:responsibilities S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Responsibilities Following Early Site Closure
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:dataDissemination S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Dissemination
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:definitions SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Supporting Details
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:clinicalLaboratoryTests S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Tests
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:regional S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Country/Region-Specific Differences
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:priorAmendments S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prior Protocol Amendment(s)
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:glossary SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Glossary of Terms and Abbreviations
..... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(ValueSet | CodeSystem) A reference to data that supports this section
.... section:references SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: References
..... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(Citation) A reference to data that supports this section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.statusrequiredCompositionStatus
http://hl7.org/fhir/ValueSet/composition-status|6.0.0-ballot3
From the FHIR Standard
Composition.typepreferredFHIRDocumentTypeCodes
http://hl7.org/fhir/ValueSet/doc-typecodes
From the FHIR Standard
Composition.relatesTo.typerequiredArtifactRelationshipType
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:citeAs.typerequiredPattern Value: cite-as
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:partOf.typerequiredPattern Value: part-of
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:derivedFrom.typerequiredPattern Value: derived-from
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:specificationOf.typerequiredPattern Value: specification-of
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:dependsOn.typerequiredPattern Value: depends-on
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:supportedWith.typerequiredPattern Value: supported-with
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.section, Composition.section:titlepage, Composition.section:summary, Composition.section:introduction, Composition.section:estimands, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:definitions, Composition.section:glossary, Composition.section:referencesA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.section, Composition.section:titlepage, Composition.section:summary, Composition.section:introduction, Composition.section:estimands, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:definitions, Composition.section:glossary, Composition.section:referencesA section can only have an emptyReason if no entries are included
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4errorCompositionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from EvidenceReport

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* EvidenceReport A set of resources composed into a single coherent clinical statement with clinical attestation
... type
.... coding 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 35528-9
..... display 1..1 string Representation defined by the system
Fixed Value: Clinical trial protocol Clinical trial protocol
.... text 0..1 string Plain text representation of the concept
Required Pattern: CeSHarP Report
... Slices for section 15..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code.text
.... section:titlepage S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Title Page
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section0-title-page
..... entry 0..* Reference(StudyDesign) A reference to data that supports this section
.... section:summary S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Summary
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section1-protocol-summary
..... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:protocolSynopsis S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Synopsis
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.1-protocol-synopsis
....... Slices for section 6..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:objectivesEndpoints S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Primary and Secondary Objectives and Estimands
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section1.1.1-objectives-estimands
......... text 1..1 Narrative Text summary of the section, for human interpretation
......... entry 0..* Reference(Composition) A reference to data that supports this section
........ section:overallDesign 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Design
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section1.1.2-overall-design
......... text 1..1 Narrative Text summary of the section, for human interpretation
......... entry 0..* Reference(Composition | ResearchStudy) A reference to data that supports this section
........ section:numberOfArms 1..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Number of Arms
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:blinding 1..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Blinding
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:numberOfParticipants 1..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Number of Participants
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:duration 0..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Duration
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:committees 1..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Committees
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:trialSchema S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Schema
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.2-trial-schema
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
...... section:scheduleOfActivities S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Schedule of Activities
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.3-schedule-of-activities
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
.... section:introduction S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Introduction
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section2-introduction
..... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:purposeOfTrial S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Purpose of Trial
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section2.1-trial-purpose
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:benefitsAndRisks S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assessment of Risks and Benefits
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2-benefits-risks
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:riskSummary 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk Summary and Mitigation Strategy
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1-risk-summary
......... text 0..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:trialIntervention S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Intervention Risks and Mitigations
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.1-trial-intervention-risk-summary
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:trialProcedures 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Procedure Risks and Mitigations
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.2-trial-procedures-risk-summary
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:otherRisk 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Other Risks and Mitigations
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.3-trial-other-risk-summary
........... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:benefitSummary S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Benefit Summary
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.2-benefit-summary
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:overallBenefitRisk 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Risk-Benefit Assessment
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.3-overall-benefit-risk-conclusion
......... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:estimands S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Objectives and Associated Estimands
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section3-estimands
..... entry 0..* Reference(StudyDesign) A reference to data that supports this section
.... section:design S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Design
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section4-trial-design
..... Slices for section 4..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:description S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Design
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.1-description-of-trial-design
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:stakeholderInput S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Stakeholder Input into Design
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.1.1-stakeholder-input-into-design
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:rationale S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Trial Design
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.2-rationale-for-trial-design
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:endpoints S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Estimand(s)
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.1-rationale-estimands
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:model S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Intervention Model
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.2-rationale-intervention-model
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:comparator S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Control Type
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.3-rationale-comparator
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:duration S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Duration
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.4-rationale-duration
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:adaptive S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Adaptive or Novel Trial Design
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.5-rationale-adaptive
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:interim S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Interim Analysis
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.6-rationale-interim-analysis
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:otherAspects S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Other Trial Design Aspects
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.7-rationale-other-aspects
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:trialStoppingRules S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Stopping Rules
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.3-trial-stopping-rules
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:startEnd S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Start of Trial and End of Trial
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.4-start-and-end
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:access S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Access to Trial Intervention After End of Trial
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.5-access-after-trial
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:population S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Population
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section5-trial-population
..... Slices for section 6..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:description S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Population and Rationale
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.1-population-description
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:inclusionCriteria S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Inclusion Criteria
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.2-inclusion-criteria
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:exclusionCriteria S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Exclusion Criteria
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.3-exclusion-criteria
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:contraception S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.4-contraception
....... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:contraceptionDefinitions S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions Related to Childbearing Potential
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.4.1-contraception-definitions
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:contraceptionDetails S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception Requirements
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.4.2-contraception-details
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:lifestyle S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Lifestyle Restrictions
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.5-lifestyle-restrictions
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:dietary S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Meals and Dietary Restrictions
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.1-dietary-restrictions
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:substances S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.2-substances-restrictions
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:activity S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Activity Restrictions
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.3-activity-restrictions
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:other S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Activity Restrictions
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.4-other-restrictions
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:screenFailures S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screen Failure and Rescreening
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.6-screen-failure
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:intervention S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Intervention and Concomitant Therapy
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section6-trial-intervention
..... text 0..1 Narrative Text summary of the section, for human interpretation
..... Slices for section 9..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:description S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Investigational Trial Intervention
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.1-description-of-trial-intervention
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
...... section:rationale S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.2-rationale-for-trial-intervention-regimen
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
...... section:dosingAdministration S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Administration
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.3-dosing-and-administration
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ActivityDefinition) A reference to data that supports this section
...... section:doseModification S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Dose Modification
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.4-dose-modification
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ActivityDefinition) A reference to data that supports this section
...... section:treatmentOfOverdose S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Investigational Trial Intervention Overdose
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.5-management-of-overdose
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ActivityDefinition | PlanDefinition) A reference to data that supports this section
...... section:preparation S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.6-preparation-storage-handling
....... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:preparationIntervention S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation of Investigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.1-preparation
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:storageHandling S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Storage and Handling of Investigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.2-storage-handling
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:accountability S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Accountability of Investigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.3-accountability
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:assignmentAndBlinding S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.7-assignment-randomisation-blinding
....... Slices for section 4..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:assignment S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Assignment to Investigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.1-assignment
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:randomisation S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Randomisation
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.2-randomisation
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:blinding S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Measures to Maintain Blinding
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.3-blinding
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:unblinding S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Unblinding at the Site
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.4-unblinding
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:adherence S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Adherence
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.8-intervention-adherence
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:noninvestigationalTherapy S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Non-Investigational Trial Intervention
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.9-noninvestigational-interventions
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:background S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Background Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.1-background-intervention
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:rescue S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rescue Therapy
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.2-rescue-therapy
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:other S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Noninvestigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.3-other-therapy
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:concomitantTherapy S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Concomitant Therapy
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.10-concomitant-therapy
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:prohibited S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prohibited Concomitant Therapy
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.10.1-prohibited-concomitant-therapy
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:permitted S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permitted Concomitant Therapy
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.10.2-permitted-concomitant-therapy
......... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:dropout S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section7-participant-discontinuation
..... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:discontinuation S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation of Trial Intervention for Individual Participants
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.1-discontinuation-of-trial-intervention
....... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:permanent S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permanent Discontinuation of Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.1-permanent-discontinuation-of-trial-intervention
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:temporary S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Temporary Discontinuation of Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.2-temporary-discontinuation-of-trial-intervention
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:rechallenge S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rechallenge
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.3-rechallenge
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:withdrawal S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation or Withdrawal from the Trial
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.2-participant-withdrawal
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:lostToFollowUp S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Loss to Follow-Up
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.3-lost-to-follow-up
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:assessments S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
..... Slices for section 8..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:considerations S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures Considerations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.1-assessments-procedures
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:screeningBaseline S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screening/Baseline Assessments and Procedures
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.2-screening-baseline-assessments
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:efficacy S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Efficacy Assessments and Procedures
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.3-efficacy-assessments
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:safety S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Assessments and Procedures
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.4-safety-assessments
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:physical S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Examination
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.1-physical-examination
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:vitals S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Vital Signs
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.2-vital-signs
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:ecg S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Electrocardiograms
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.3-electrocardiograms
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:laboratory S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Assessments
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.4-clinical-laboratory-assessments
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:pregnancy S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy Testing
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.5-pregnancy-testing
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:suicidal S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.6-suicidal-ideation
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:pharmacokinetics S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacokinetics
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.5-pharmacokinetics
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:biomarkers S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Biomarkers
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.6-biomarkers
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:genetics S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Genetics and Pharmacogenomics
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.1-genetics-pharmacogenomics
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:pharmacodynamics S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacodynamic Biomarkers
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.2-pharmacodynamics
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:other S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Biomarkers
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.3-other-biomarkers
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:immunogenicity S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Immunogenicity Assessments
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.7-immunogenicity-assessments
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:economics S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Medical Resource Utilisation and Health Economics
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.8-economics
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:adverseEvents S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events, Serious Adverse Events, Product Complaints, Pregnancy and Postpartum Information, and Special Safety Situations
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section9-adverse-events
..... Slices for section 4..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:definitions S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.1-definitions
....... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:adverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Adverse Events
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.1-definitions-adverse-events
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:seriousAdverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Serious Adverse Events
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.2-definitions-serious-adverse-events
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:productComplaintsDefinitions S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Product Complaints
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.3-definitions-product-complaints
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:collectionMethods S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing and Procedures for Collection and Reporting
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2-collection-methods
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 5..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:timing 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.1-timing
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:procedures 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Collection Procedures
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2-collection-procedures
......... text 1..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 5..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:identifying 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Identification
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.1-identification
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:intensity 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Severity
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.2-severity
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:causality 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Causality
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.3-causality
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:recording 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Recording
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.4-recording
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:followup 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Follow-up
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.5-followup
........... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:reporting 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Reporting
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.3-reporting-events
......... text 1..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 1..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:regulatoryRequirements 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory Reporting Requirements
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.3.1-regulatory-requirements
........... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:specialInterest 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events of Special Interest
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.4-special-interest
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:diseaseRelatedEvents 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.5-disease-related-events
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:pregnancy S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy and Postpartum Information
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.3-pregnancy-postpartum
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:pregnant S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Who Become Pregnant During the Trial
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.3.1-pregnant
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:pregnantPartner S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Whose Partners Become Pregnant
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.3.2-pregnant-partner
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:special S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Special Safety Situations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.4-special-safety-situations
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:statistics S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Considerations
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section10-statistics
..... text 0..1 Narrative Text summary of the section, for human interpretation
..... Slices for section 6..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:considerations S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: General Considerations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.1-general-considerations
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:analysisSets S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analysis Sets
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.2-analysis-sets
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:analysisBaseline S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses of Demographics and Other Baseline Variables
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.3-analyses-demographics
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:analysisPrimaryObjective S 1..* BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Primary Objective(s)
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4-analysis-primary-objective
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 1..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:analysisPrimaryInstance S 1..* BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1-analysis-primary-objective-instance
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text 0..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:statisticalModel S 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.1-statistical-method
........... text 1..1 Narrative Text summary of the section, for human interpretation
........... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Primary Estimand(s)
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.2-data-handling
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:missingData S 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.3-missing-data-handling
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:sensitvityAnalysis S 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.4-sensitivity-analysis
........... text 1..1 Narrative Text summary of the section, for human interpretation
........... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.5-supplementary-analysis
........... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:secondaryAnalysis S 0..* BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Secondary Objective(s)
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5-analysis-secondary-objective
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 1..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:analysisSecondaryInstance S 1..* BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1-analysis-secondary-objective-instance
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text 0..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:statisticalModel S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.1-statistical-method
........... text 1..1 Narrative Text summary of the section, for human interpretation
........... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.2-data-handling
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:missingData S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.3-missing-data-handling
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:sensitvityAnalysis S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.4-sensitivity-analysis
........... text 1..1 Narrative Text summary of the section, for human interpretation
........... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.5-supplementary-analysis
........... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:exploratoryAnalysis S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Exploratory Objective(s)
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.6-analysis-exploratory-objective
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:safetyAnalyses S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Analyses
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.7-safety-analyses
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:otherAnalyses S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Analyses
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.8-other-analyses
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:multiplicity S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Multiplicity Adjustments
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.10-multiplicity-adjustments
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:interimAnalyses S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Interim Analyses
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.9-interim-analyses
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:sampleSize S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sample Size Determination
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.11-sample-size-determination
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.... section:oversight S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight and Other General Considerations
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section11-oversight
..... Slices for section 12..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:regulatory S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory and Ethical Considerations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.1-regulatory-considerations
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:trialOversight S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.2-trial-oversight
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:investigatorResponsibilities S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigator Responsibilities
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.2.1-investigator-responsibilities
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:sponsorResponsibilities S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sponsor Responsibilities
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.2.2-sponsor-responsibilities
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:committees S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Committees
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.4-committees
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:informedConsent S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent Process
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.3-informed-consent-process
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:assentProcess S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assent Process
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.0-assent-process
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:emergency S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Consent Process
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.0-emergency-consent-process
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:rescreening S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Rescreening
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.1-rescreening-consent-process
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:remainingSamples S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.2-remaining-samples
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:insurance S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Insurance and Indemnity
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.5-insurance-and-indemnity
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:riskManagement S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk-Based Quality Management
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.6-risk-management
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:dataGovernance S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Governance
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.7-data-governance
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:dataProtection S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Protection
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.8-data-protection
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:sourceData S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Source Data
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.9-source-data
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:protcolDeviations S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Deviations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.10-protocol-deviations
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:earlySiteClosure S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Early Site Closure
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure
....... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:decisionRights S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Decision Rights for Site Closure
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#decisionRights
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:criteria S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Crteria for Early Closure
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#criteria
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:responsibilities S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Responsibilities Following Early Site Closure
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#responsibilities
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:dataDissemination S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Dissemination
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.12-data-dissemination
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:definitions S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Supporting Details
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section12-supporting-details
..... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:clinicalLaboratoryTests S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Tests
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.1-clinical-laboratory-tests
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:regional S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Country/Region-Specific Differences
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.2-country-specific-differences
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:priorAmendments S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prior Protocol Amendment(s)
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.3-prior-protocol-amendments
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:glossary S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Glossary of Terms and Abbreviations
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section13-glossary
..... text 1..1 Narrative Text summary of the section, for human interpretation
..... entry 0..* Reference(ValueSet | CodeSystem) A reference to data that supports this section
.... section:references S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: References
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section14-references
..... text 1..1 Narrative Text summary of the section, for human interpretation
..... entry 0..* Reference(Citation) A reference to data that supports this section

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* EvidenceReport A set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:versionAlgorithm 0..1 Coding How to compare versions
URL: http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
Binding: VersionAlgorithm (extensible)
.... extension:experimental 0..1 boolean For testing purposes, not real usage
URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental
.... extension:description 0..1 markdown Natural language description of the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-description
.... extension:purpose 0..1 markdown Why this artifact is defined
URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose
.... extension:copyright 0..1 markdown Use and/or publishing restrictions
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright
.... extension:copyrightLabel 0..1 string Copyright holder and year(s)
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel
.... extension:approvalDate 0..1 date When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-approvalDate
.... extension:lastReviewDate 0..1 date When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-lastReviewDate
.... extension:effectivePeriod 0..1 Period When the artifact is expected to be used
URL: http://hl7.org/fhir/StructureDefinition/artifact-effectivePeriod
.... extension:additionalLanguage 0..* code The additional language
URL: http://hl7.org/fhir/StructureDefinition/additional-language
Binding: AllLanguages (required): IETF language tag for a human language
.... extension:extendedContactDetail 0..* ExtendedContactDetail Contact details for the publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-extended-contact-detail
.... extension:publicationDate 0..1 date Publication date of Resource
URL: http://hl7.org/fhir/StructureDefinition/artifact-publicationDate
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url Σ 0..1 uri Canonical identifier for this Composition, represented as a URI (globally unique)
... identifier Σ 0..* Identifier Version-independent identifier for the Composition
... version Σ 0..1 string An explicitly assigned identifier of a variation of the content in the Composition
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 35528-9
..... display 1..1 string Representation defined by the system
Fixed Value: Clinical trial protocol Clinical trial protocol
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
Required Pattern: CeSHarP Report
... category Σ 0..* CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
... subject Σ 0..* Reference(Resource) Who and/or what the composition is about
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Composition editing time
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author Σ 1..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the composition
... name Σ 0..1 string Name for this Composition (computer friendly)
... title Σ 1..1 string Human Readable name/title
... note 0..* Annotation For any additional notes
... attester 0..* BackboneElement Attests to accuracy of composition
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... mode 1..1 CodeableConcept reviewer | editor | endorser | informant | recorder
Binding: Contributor Role (preferred)
.... time 0..1 dateTime When the composition was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) Who attested the composition
... custodian Σ 0..1 Reference(Organization) Organization which maintains the composition
... Slices for relatesTo 0..* BackboneElement Relationships to other compositions/documents
Slice: Unordered, Open by value:type
.... relatesTo:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:citeAs 0..1 BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: cite-as
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:partOf 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: part-of
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:derivedFrom 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: derived-from
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:specificationOf 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: specification-of
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:dependsOn 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: depends-on
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:supportedWith 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: supported-with
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
... event Σ 0..* BackboneElement The clinical service(s) being documented
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... period Σ 0..1 Period The period covered by the documentation
.... detail Σ 0..* CodeableReference(Resource) The event(s) being documented, as code(s), reference(s), or both
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
... Slices for section C 15..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code.text
Constraints: cmp-1, cmp-2
.... section:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section
.... section:titlepage SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Title Page
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section0-title-page
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(StudyDesign) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section
.... section:summary SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Summary
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section1-protocol-summary
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:protocolSynopsis S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Synopsis
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.1-protocol-synopsis
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:objectivesEndpoints S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Primary and Secondary Objectives and Estimands
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section1.1.1-objectives-estimands
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Composition) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:overallDesign 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Design
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section1.1.2-overall-design
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Composition | ResearchStudy) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:numberOfArms 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Number of Arms
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:blinding 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Blinding
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:numberOfParticipants 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Number of Participants
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:duration 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Duration
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:committees 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Committees
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:trialSchema S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Schema
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.2-trial-schema
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:scheduleOfActivities S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Schedule of Activities
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.3-schedule-of-activities
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:introduction SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Introduction
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section2-introduction
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:purposeOfTrial S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Purpose of Trial
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section2.1-trial-purpose
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:benefitsAndRisks S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assessment of Risks and Benefits
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2-benefits-risks
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:riskSummary 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk Summary and Mitigation Strategy
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1-risk-summary
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:trialIntervention S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Intervention Risks and Mitigations
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.1-trial-intervention-risk-summary
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:trialProcedures 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Procedure Risks and Mitigations
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.2-trial-procedures-risk-summary
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:otherRisk 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Other Risks and Mitigations
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.3-trial-other-risk-summary
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
........ section:benefitSummary S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Benefit Summary
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.2-benefit-summary
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:overallBenefitRisk 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Risk-Benefit Assessment
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.3-overall-benefit-risk-conclusion
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
.... section:estimands SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Objectives and Associated Estimands
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section3-estimands
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(StudyDesign) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section
.... section:design SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Design
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section4-trial-design
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:description S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Design
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.1-description-of-trial-design
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:stakeholderInput S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Stakeholder Input into Design
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.1.1-stakeholder-input-into-design
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:rationale S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Trial Design
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.2-rationale-for-trial-design
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:endpoints S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Estimand(s)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.1-rationale-estimands
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:model S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Intervention Model
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.2-rationale-intervention-model
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:comparator S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Control Type
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.3-rationale-comparator
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:duration S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Duration
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.4-rationale-duration
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:adaptive S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Adaptive or Novel Trial Design
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.5-rationale-adaptive
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:interim S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Interim Analysis
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.6-rationale-interim-analysis
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:otherAspects S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Other Trial Design Aspects
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.7-rationale-other-aspects
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:trialStoppingRules S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Stopping Rules
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.3-trial-stopping-rules
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:startEnd S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Start of Trial and End of Trial
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.4-start-and-end
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:access S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Access to Trial Intervention After End of Trial
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.5-access-after-trial
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:population SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Population
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section5-trial-population
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:description S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Population and Rationale
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.1-population-description
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:inclusionCriteria S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Inclusion Criteria
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.2-inclusion-criteria
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:exclusionCriteria S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Exclusion Criteria
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.3-exclusion-criteria
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:contraception S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.4-contraception
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:contraceptionDefinitions S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions Related to Childbearing Potential
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.4.1-contraception-definitions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:contraceptionDetails S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception Requirements
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.4.2-contraception-details
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:lifestyle S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Lifestyle Restrictions
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.5-lifestyle-restrictions
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:dietary S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Meals and Dietary Restrictions
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.1-dietary-restrictions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:substances S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.2-substances-restrictions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:activity S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Activity Restrictions
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.3-activity-restrictions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:other S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Activity Restrictions
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.4-other-restrictions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:screenFailures S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screen Failure and Rescreening
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.6-screen-failure
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:intervention SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Intervention and Concomitant Therapy
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section6-trial-intervention
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 9..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:description S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Investigational Trial Intervention
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.1-description-of-trial-intervention
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:rationale S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.2-rationale-for-trial-intervention-regimen
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:dosingAdministration S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Administration
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.3-dosing-and-administration
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ActivityDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:doseModification S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Dose Modification
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.4-dose-modification
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ActivityDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:treatmentOfOverdose S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Investigational Trial Intervention Overdose
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.5-management-of-overdose
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ActivityDefinition | PlanDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:preparation S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.6-preparation-storage-handling
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:preparationIntervention S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation of Investigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.1-preparation
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:storageHandling S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Storage and Handling of Investigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.2-storage-handling
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:accountability S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Accountability of Investigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.3-accountability
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:assignmentAndBlinding S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.7-assignment-randomisation-blinding
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:assignment S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Assignment to Investigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.1-assignment
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:randomisation S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Randomisation
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.2-randomisation
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:blinding S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Measures to Maintain Blinding
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.3-blinding
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:unblinding S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Unblinding at the Site
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.4-unblinding
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:adherence S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Adherence
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.8-intervention-adherence
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:noninvestigationalTherapy S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Non-Investigational Trial Intervention
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.9-noninvestigational-interventions
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:background S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Background Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.1-background-intervention
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:rescue S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rescue Therapy
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.2-rescue-therapy
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:other S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Noninvestigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.3-other-therapy
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:concomitantTherapy S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Concomitant Therapy
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.10-concomitant-therapy
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:prohibited S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prohibited Concomitant Therapy
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.10.1-prohibited-concomitant-therapy
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:permitted S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permitted Concomitant Therapy
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.10.2-permitted-concomitant-therapy
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
.... section:dropout SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section7-participant-discontinuation
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:discontinuation S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation of Trial Intervention for Individual Participants
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.1-discontinuation-of-trial-intervention
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:permanent S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permanent Discontinuation of Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.1-permanent-discontinuation-of-trial-intervention
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:temporary S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Temporary Discontinuation of Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.2-temporary-discontinuation-of-trial-intervention
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:rechallenge S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rechallenge
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.3-rechallenge
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:withdrawal S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation or Withdrawal from the Trial
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.2-participant-withdrawal
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:lostToFollowUp S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Loss to Follow-Up
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.3-lost-to-follow-up
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:assessments SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 8..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:considerations S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures Considerations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.1-assessments-procedures
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:screeningBaseline S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screening/Baseline Assessments and Procedures
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.2-screening-baseline-assessments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:efficacy S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Efficacy Assessments and Procedures
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.3-efficacy-assessments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:safety S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Assessments and Procedures
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.4-safety-assessments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:physical S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Examination
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.1-physical-examination
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:vitals S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Vital Signs
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.2-vital-signs
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:ecg S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Electrocardiograms
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.3-electrocardiograms
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:laboratory S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Assessments
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.4-clinical-laboratory-assessments
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:pregnancy S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy Testing
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.5-pregnancy-testing
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:suicidal S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.6-suicidal-ideation
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:pharmacokinetics S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacokinetics
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.5-pharmacokinetics
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:biomarkers S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Biomarkers
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.6-biomarkers
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:genetics S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Genetics and Pharmacogenomics
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.1-genetics-pharmacogenomics
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:pharmacodynamics S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacodynamic Biomarkers
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.2-pharmacodynamics
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:other S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Biomarkers
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.3-other-biomarkers
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:immunogenicity S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Immunogenicity Assessments
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.7-immunogenicity-assessments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:economics S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Medical Resource Utilisation and Health Economics
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.8-economics
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:adverseEvents SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events, Serious Adverse Events, Product Complaints, Pregnancy and Postpartum Information, and Special Safety Situations
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section9-adverse-events
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:definitions S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.1-definitions
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:adverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Adverse Events
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.1-definitions-adverse-events
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:seriousAdverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Serious Adverse Events
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.2-definitions-serious-adverse-events
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:productComplaintsDefinitions S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Product Complaints
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.3-definitions-product-complaints
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:collectionMethods S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing and Procedures for Collection and Reporting
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2-collection-methods
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 5..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:timing 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.1-timing
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:procedures 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Collection Procedures
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2-collection-procedures
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 5..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:identifying 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Identification
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.1-identification
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:intensity 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Severity
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.2-severity
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:causality 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Causality
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.3-causality
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:recording 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Recording
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.4-recording
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:followup 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Follow-up
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.5-followup
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
........ section:reporting 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Reporting
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.3-reporting-events
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:regulatoryRequirements 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory Reporting Requirements
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.3.1-regulatory-requirements
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
........ section:specialInterest 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events of Special Interest
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.4-special-interest
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:diseaseRelatedEvents 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.5-disease-related-events
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:pregnancy S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy and Postpartum Information
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.3-pregnancy-postpartum
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:pregnant S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Who Become Pregnant During the Trial
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.3.1-pregnant
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:pregnantPartner S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Whose Partners Become Pregnant
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.3.2-pregnant-partner
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:special S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Special Safety Situations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.4-special-safety-situations
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:statistics SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Considerations
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section10-statistics
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:considerations S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: General Considerations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.1-general-considerations
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:analysisSets S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analysis Sets
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.2-analysis-sets
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:analysisBaseline S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses of Demographics and Other Baseline Variables
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.3-analyses-demographics
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:analysisPrimaryObjective S 1..* BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Primary Objective(s)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4-analysis-primary-objective
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:analysisPrimaryInstance S 1..* BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1-analysis-primary-objective-instance
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:statisticalModel S 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.1-statistical-method
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Primary Estimand(s)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.2-data-handling
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:missingData S 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.3-missing-data-handling
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:sensitvityAnalysis S 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.4-sensitivity-analysis
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.5-supplementary-analysis
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
...... section:secondaryAnalysis S 0..* BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Secondary Objective(s)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5-analysis-secondary-objective
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:analysisSecondaryInstance S 1..* BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1-analysis-secondary-objective-instance
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:statisticalModel S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.1-statistical-method
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.2-data-handling
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:missingData S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.3-missing-data-handling
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:sensitvityAnalysis S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.4-sensitivity-analysis
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.5-supplementary-analysis
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
...... section:exploratoryAnalysis S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Exploratory Objective(s)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.6-analysis-exploratory-objective
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:safetyAnalyses S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Analyses
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.7-safety-analyses
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:otherAnalyses S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Analyses
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.8-other-analyses
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:multiplicity S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Multiplicity Adjustments
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.10-multiplicity-adjustments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:interimAnalyses S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Interim Analyses
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.9-interim-analyses
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:sampleSize S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sample Size Determination
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.11-sample-size-determination
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:oversight SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight and Other General Considerations
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section11-oversight
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 12..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:regulatory S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory and Ethical Considerations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.1-regulatory-considerations
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:trialOversight S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.2-trial-oversight
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:investigatorResponsibilities S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigator Responsibilities
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.2.1-investigator-responsibilities
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:sponsorResponsibilities S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sponsor Responsibilities
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.2.2-sponsor-responsibilities
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:committees S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Committees
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.4-committees
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:informedConsent S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent Process
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.3-informed-consent-process
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:assentProcess S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assent Process
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.0-assent-process
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:emergency S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Consent Process
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.0-emergency-consent-process
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:rescreening S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Rescreening
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.1-rescreening-consent-process
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:remainingSamples S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.2-remaining-samples
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:insurance S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Insurance and Indemnity
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.5-insurance-and-indemnity
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:riskManagement S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk-Based Quality Management
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.6-risk-management
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:dataGovernance S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Governance
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.7-data-governance
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:dataProtection S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Protection
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.8-data-protection
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:sourceData S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Source Data
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.9-source-data
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:protcolDeviations S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Deviations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.10-protocol-deviations
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:earlySiteClosure S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Early Site Closure
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:decisionRights S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Decision Rights for Site Closure
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#decisionRights
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:criteria S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Crteria for Early Closure
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#criteria
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:responsibilities S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Responsibilities Following Early Site Closure
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#responsibilities
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:dataDissemination S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Dissemination
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.12-data-dissemination
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:definitions SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Supporting Details
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section12-supporting-details
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:clinicalLaboratoryTests S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Tests
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.1-clinical-laboratory-tests
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:regional S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Country/Region-Specific Differences
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.2-country-specific-differences
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:priorAmendments S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prior Protocol Amendment(s)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.3-prior-protocol-amendments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:glossary SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Glossary of Terms and Abbreviations
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section13-glossary
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(ValueSet | CodeSystem) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section
.... section:references SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: References
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section14-references
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Citation) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3
From the FHIR Standard
Composition.statusrequiredCompositionStatus
http://hl7.org/fhir/ValueSet/composition-status|6.0.0-ballot3
From the FHIR Standard
Composition.typepreferredFHIRDocumentTypeCodes
http://hl7.org/fhir/ValueSet/doc-typecodes
From the FHIR Standard
Composition.categoryexampleReferencedItemCategoryValueSet
http://hl7.org/fhir/ValueSet/referenced-item-category
From the FHIR Standard
Composition.attester.modepreferredContributorRole
http://terminology.hl7.org/ValueSet/contributor-role
Composition.relatesTo.typerequiredArtifactRelationshipType
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:citeAs.typerequiredPattern Value: cite-as
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:partOf.typerequiredPattern Value: part-of
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:derivedFrom.typerequiredPattern Value: derived-from
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:specificationOf.typerequiredPattern Value: specification-of
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:dependsOn.typerequiredPattern Value: depends-on
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:supportedWith.typerequiredPattern Value: supported-with
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.event.detailexampleActCode
http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:titlepage.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:titlepage.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:titlepage.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:summary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:summary.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:overallDesign.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:overallDesign.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:overallDesign.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:blinding.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:blinding.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:blinding.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:duration.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:duration.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:duration.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:committees.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:committees.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:committees.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:trialSchema.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:trialSchema.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:trialSchema.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:scheduleOfActivities.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:scheduleOfActivities.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:scheduleOfActivities.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:introduction.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:introduction.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:purposeOfTrial.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:purposeOfTrial.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:purposeOfTrial.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:estimands.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:estimands.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:estimands.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:design.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:design.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:description.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:description.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:description.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:description.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:description.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:description.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:description.section:stakeholderInput.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:description.section:stakeholderInput.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:description.section:stakeholderInput.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:endpoints.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:endpoints.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:endpoints.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:model.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:model.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:model.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:comparator.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:comparator.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:comparator.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:duration.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:duration.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:duration.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:adaptive.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:adaptive.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:adaptive.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:interim.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:interim.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:interim.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:otherAspects.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:otherAspects.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:otherAspects.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:trialStoppingRules.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:trialStoppingRules.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:trialStoppingRules.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:startEnd.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:startEnd.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:startEnd.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:access.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:access.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:access.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:population.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:population.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:description.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:description.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:description.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:inclusionCriteria.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:inclusionCriteria.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:inclusionCriteria.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:exclusionCriteria.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:exclusionCriteria.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:exclusionCriteria.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:contraception.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:contraception.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:contraception.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:contraception.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:contraception.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:contraception.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDefinitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDefinitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDefinitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDetails.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDetails.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDetails.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section:dietary.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section:dietary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section:dietary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section:substances.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section:substances.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section:substances.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section:activity.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section:activity.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section:activity.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section:other.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section:other.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section:other.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:screenFailures.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:screenFailures.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:screenFailures.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:intervention.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:intervention.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:description.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:description.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:description.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:rationale.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:rationale.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:rationale.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:dosingAdministration.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:dosingAdministration.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:dosingAdministration.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:doseModification.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:doseModification.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:doseModification.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:treatmentOfOverdose.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:treatmentOfOverdose.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:treatmentOfOverdose.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.section:preparationIntervention.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.section:preparationIntervention.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.section:preparationIntervention.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.section:storageHandling.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.section:storageHandling.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.section:storageHandling.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.section:accountability.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.section:accountability.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.section:accountability.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:adherence.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:adherence.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:adherence.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:background.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:background.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:background.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:other.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:other.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:other.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:prohibited.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:prohibited.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:prohibited.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:permitted.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:permitted.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:permitted.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:dropout.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:dropout.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:permanent.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:permanent.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:permanent.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:temporary.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:temporary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:temporary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:rechallenge.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:rechallenge.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:rechallenge.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:withdrawal.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:withdrawal.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:withdrawal.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:lostToFollowUp.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:lostToFollowUp.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:lostToFollowUp.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:assessments.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:assessments.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:considerations.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:considerations.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:considerations.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:screeningBaseline.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:screeningBaseline.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:screeningBaseline.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:efficacy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:efficacy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:efficacy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:physical.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:physical.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:physical.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:vitals.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:vitals.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:vitals.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:ecg.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:ecg.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:ecg.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:laboratory.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:laboratory.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:laboratory.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:pregnancy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:pregnancy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:pregnancy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:suicidal.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:suicidal.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:suicidal.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:pharmacokinetics.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:pharmacokinetics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:pharmacokinetics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:genetics.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:genetics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:genetics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:pharmacodynamics.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:pharmacodynamics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:pharmacodynamics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:other.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:other.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:other.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:immunogenicity.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:immunogenicity.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:immunogenicity.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:economics.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:economics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:economics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:adverseEvents.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:adverseEvents.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:timing.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:timing.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:timing.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:identifying.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:identifying.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:identifying.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:intensity.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:intensity.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:intensity.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:causality.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:causality.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:causality.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:recording.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:recording.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:recording.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:followup.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:followup.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:followup.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section:regulatoryRequirements.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section:regulatoryRequirements.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section:regulatoryRequirements.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:specialInterest.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:specialInterest.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:specialInterest.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:diseaseRelatedEvents.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:diseaseRelatedEvents.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:diseaseRelatedEvents.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnant.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnant.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnant.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:special.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:special.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:special.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:statistics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:statistics.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:considerations.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:considerations.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:considerations.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisSets.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisSets.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisSets.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisBaseline.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisBaseline.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisBaseline.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:statisticalModel.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:statisticalModel.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:statisticalModel.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:intercurrentEventHandling.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:intercurrentEventHandling.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:intercurrentEventHandling.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:missingData.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:missingData.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:missingData.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:sensitvityAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:sensitvityAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:sensitvityAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:supplementaryAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:supplementaryAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:supplementaryAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:statisticalModel.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:statisticalModel.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:statisticalModel.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:intercurrentEventHandling.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:intercurrentEventHandling.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:intercurrentEventHandling.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:missingData.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:missingData.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:missingData.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:sensitvityAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:sensitvityAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:sensitvityAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:supplementaryAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:supplementaryAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:supplementaryAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:exploratoryAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:exploratoryAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:exploratoryAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:safetyAnalyses.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:safetyAnalyses.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:safetyAnalyses.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:otherAnalyses.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:otherAnalyses.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:otherAnalyses.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:multiplicity.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:multiplicity.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:multiplicity.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:interimAnalyses.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:interimAnalyses.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:interimAnalyses.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:sampleSize.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:sampleSize.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:sampleSize.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:oversight.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:oversight.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:regulatory.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:regulatory.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:regulatory.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:trialOversight.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:trialOversight.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:trialOversight.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:committees.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:committees.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:committees.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:assentProcess.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:assentProcess.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:assentProcess.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:emergency.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:emergency.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:emergency.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:rescreening.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:rescreening.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:rescreening.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:remainingSamples.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:remainingSamples.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:remainingSamples.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:insurance.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:insurance.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:insurance.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:riskManagement.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:riskManagement.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:riskManagement.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:dataGovernance.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:dataGovernance.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:dataGovernance.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:dataProtection.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:dataProtection.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:dataProtection.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:sourceData.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:sourceData.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:sourceData.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:protcolDeviations.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:protcolDeviations.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:protcolDeviations.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:criteria.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:criteria.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:criteria.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:dataDissemination.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:dataDissemination.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:dataDissemination.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:definitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:definitions.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.section:clinicalLaboratoryTests.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:definitions.section:clinicalLaboratoryTests.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.section:clinicalLaboratoryTests.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.section:regional.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:definitions.section:regional.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.section:regional.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.section:priorAmendments.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:definitions.section:priorAmendments.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.section:priorAmendments.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:glossary.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:glossary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:glossary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:references.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:references.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:references.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.section, Composition.section:titlepage, Composition.section:summary, Composition.section:introduction, Composition.section:estimands, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:definitions, Composition.section:glossary, Composition.section:referencesA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.section, Composition.section:titlepage, Composition.section:summary, Composition.section:introduction, Composition.section:estimands, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:definitions, Composition.section:glossary, Composition.section:referencesA section can only have an emptyReason if no entries are included
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4errorCompositionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from EvidenceReport

Summary

Mandatory: 205 elements(225 nested mandatory elements)
Must-Support: 149 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Composition.section
  • The element 1 is sliced based on the value of Composition.section.section
  • The element 1 is sliced based on the value of Composition.section.section.section
  • The element 1 is sliced based on the value of Composition.section.section.section.section

Maturity: 1

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* EvidenceReport A set of resources composed into a single coherent clinical statement with clinical attestation
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension Content/Rules for all slices
.... extension:versionAlgorithm 0..1 Coding How to compare versions
URL: http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
Binding: VersionAlgorithm (extensible)
.... extension:experimental 0..1 boolean For testing purposes, not real usage
URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental
.... extension:description 0..1 markdown Natural language description of the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-description
.... extension:purpose 0..1 markdown Why this artifact is defined
URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose
.... extension:copyright 0..1 markdown Use and/or publishing restrictions
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright
.... extension:copyrightLabel 0..1 string Copyright holder and year(s)
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel
.... extension:approvalDate 0..1 date When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-approvalDate
.... extension:lastReviewDate 0..1 date When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-lastReviewDate
.... extension:effectivePeriod 0..1 Period When the artifact is expected to be used
URL: http://hl7.org/fhir/StructureDefinition/artifact-effectivePeriod
.... extension:additionalLanguage 0..* code The additional language
URL: http://hl7.org/fhir/StructureDefinition/additional-language
Binding: AllLanguages (required): IETF language tag for a human language
.... extension:extendedContactDetail 0..* ExtendedContactDetail Contact details for the publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-extended-contact-detail
.... extension:publicationDate 0..1 date Publication date of Resource
URL: http://hl7.org/fhir/StructureDefinition/artifact-publicationDate
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
.... coding 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 35528-9
..... display 1..1 string Representation defined by the system
Fixed Value: Clinical trial protocol Clinical trial protocol
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
Required Pattern: CeSHarP Report
... date Σ 1..1 dateTime Composition editing time
... author Σ 1..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the composition
... title Σ 1..1 string Human Readable name/title
... Slices for relatesTo 0..* BackboneElement Relationships to other compositions/documents
Slice: Unordered, Open by value:type
.... relatesTo:All Slices Content/Rules for all slices
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:citeAs 0..1 BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: cite-as
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:partOf 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: part-of
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:derivedFrom 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: derived-from
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:specificationOf 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: specification-of
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:dependsOn 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: depends-on
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:supportedWith 0..* BackboneElement Relationships to other compositions/documents
..... Slices for extension Content/Rules for all slices
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: supported-with
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
... Slices for section C 15..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code.text
Constraints: cmp-1, cmp-2
.... section:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:titlepage SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Title Page
..... entry C 0..* Reference(StudyDesign) A reference to data that supports this section
.... section:summary SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Summary
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:protocolSynopsis S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Synopsis
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:objectivesEndpoints S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Primary and Secondary Objectives and Estimands
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Composition) A reference to data that supports this section
........ section:overallDesign 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Design
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Composition | ResearchStudy) A reference to data that supports this section
........ section:numberOfArms 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:blinding 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:numberOfParticipants 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:duration 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:committees 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:trialSchema S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Schema
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
...... section:scheduleOfActivities S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Schedule of Activities
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
.... section:introduction SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Introduction
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:purposeOfTrial S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Purpose of Trial
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:benefitsAndRisks S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assessment of Risks and Benefits
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:riskSummary 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk Summary and Mitigation Strategy
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:trialIntervention S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Intervention Risks and Mitigations
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:trialProcedures 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Procedure Risks and Mitigations
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:otherRisk 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Other Risks and Mitigations
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:benefitSummary S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Benefit Summary
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:overallBenefitRisk 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Risk-Benefit Assessment
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:estimands SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Objectives and Associated Estimands
..... entry C 0..* Reference(StudyDesign) A reference to data that supports this section
.... section:design SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Design
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:description S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Design
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:stakeholderInput S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Stakeholder Input into Design
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:rationale S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Trial Design
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:endpoints S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Estimand(s)
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:model S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Intervention Model
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:comparator S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Control Type
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:duration S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Duration
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:adaptive S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Adaptive or Novel Trial Design
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:interim S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Interim Analysis
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:otherAspects S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Other Trial Design Aspects
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:trialStoppingRules S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Stopping Rules
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:startEnd S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Start of Trial and End of Trial
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:access S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Access to Trial Intervention After End of Trial
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:population SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Population
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:description S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Population and Rationale
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:inclusionCriteria S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Inclusion Criteria
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:exclusionCriteria S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Exclusion Criteria
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:contraception S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:contraceptionDefinitions S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions Related to Childbearing Potential
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:contraceptionDetails S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception Requirements
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:lifestyle S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Lifestyle Restrictions
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:dietary S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Meals and Dietary Restrictions
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:substances S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:activity S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Activity Restrictions
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:other S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Activity Restrictions
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:screenFailures S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screen Failure and Rescreening
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:intervention SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Intervention and Concomitant Therapy
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 9..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:description S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Investigational Trial Intervention
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
...... section:rationale S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
...... section:dosingAdministration S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Administration
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ActivityDefinition) A reference to data that supports this section
...... section:doseModification S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Dose Modification
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ActivityDefinition) A reference to data that supports this section
...... section:treatmentOfOverdose S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Investigational Trial Intervention Overdose
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(ActivityDefinition | PlanDefinition) A reference to data that supports this section
...... section:preparation S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:preparationIntervention S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation of Investigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:storageHandling S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Storage and Handling of Investigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:accountability S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Accountability of Investigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:assignmentAndBlinding S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:assignment S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Assignment to Investigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:randomisation S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Randomisation
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:blinding S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Measures to Maintain Blinding
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:unblinding S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Unblinding at the Site
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:adherence S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Adherence
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:noninvestigationalTherapy S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Non-Investigational Trial Intervention
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:background S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Background Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:rescue S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rescue Therapy
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:other S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Noninvestigational Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:concomitantTherapy S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Concomitant Therapy
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:prohibited S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prohibited Concomitant Therapy
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:permitted S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permitted Concomitant Therapy
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:dropout SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:discontinuation S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation of Trial Intervention for Individual Participants
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:permanent S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permanent Discontinuation of Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:temporary S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Temporary Discontinuation of Trial Intervention
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:rechallenge S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rechallenge
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:withdrawal S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation or Withdrawal from the Trial
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:lostToFollowUp S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Loss to Follow-Up
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:assessments SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 8..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:considerations S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures Considerations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:screeningBaseline S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screening/Baseline Assessments and Procedures
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:efficacy S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Efficacy Assessments and Procedures
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:safety S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Assessments and Procedures
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:physical S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Examination
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:vitals S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Vital Signs
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:ecg S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Electrocardiograms
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:laboratory S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Assessments
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:pregnancy S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy Testing
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:suicidal S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:pharmacokinetics S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacokinetics
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:biomarkers S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Biomarkers
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:genetics S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Genetics and Pharmacogenomics
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:pharmacodynamics S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacodynamic Biomarkers
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:other S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Biomarkers
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:immunogenicity S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Immunogenicity Assessments
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:economics S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Medical Resource Utilisation and Health Economics
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:adverseEvents SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events, Serious Adverse Events, Product Complaints, Pregnancy and Postpartum Information, and Special Safety Situations
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:definitions S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:adverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Adverse Events
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:seriousAdverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Serious Adverse Events
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:productComplaintsDefinitions S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Product Complaints
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:collectionMethods S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing and Procedures for Collection and Reporting
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 5..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:timing 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:procedures 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Collection Procedures
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 5..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:identifying 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Identification
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:intensity 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Severity
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:causality 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Causality
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:recording 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Recording
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:followup 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Follow-up
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:reporting 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Reporting
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:regulatoryRequirements 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory Reporting Requirements
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:specialInterest 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events of Special Interest
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:diseaseRelatedEvents 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:pregnancy S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy and Postpartum Information
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:pregnant S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Who Become Pregnant During the Trial
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:pregnantPartner S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Whose Partners Become Pregnant
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:special S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Special Safety Situations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:statistics SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Considerations
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:considerations S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: General Considerations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:analysisSets S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analysis Sets
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:analysisBaseline S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses of Demographics and Other Baseline Variables
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:analysisPrimaryObjective S 1..* BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Primary Objective(s)
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:analysisPrimaryInstance S 1..* BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:statisticalModel S 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Primary Estimand(s)
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:missingData S 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:sensitvityAnalysis S 1..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:secondaryAnalysis S 0..* BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Secondary Objective(s)
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:analysisSecondaryInstance S 1..* BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:statisticalModel S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:missingData S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
.......... section:sensitvityAnalysis S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:exploratoryAnalysis S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Exploratory Objective(s)
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:safetyAnalyses S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Analyses
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:otherAnalyses S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Analyses
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:multiplicity S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Multiplicity Adjustments
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:interimAnalyses S 0..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Interim Analyses
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:sampleSize S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sample Size Determination
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.... section:oversight SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight and Other General Considerations
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 12..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:regulatory S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory and Ethical Considerations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:trialOversight S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:investigatorResponsibilities S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigator Responsibilities
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:sponsorResponsibilities S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sponsor Responsibilities
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:committees S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Committees
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:informedConsent S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent Process
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:assentProcess S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assent Process
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:emergency S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Consent Process
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:rescreening S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Rescreening
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:remainingSamples S 0..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:insurance S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Insurance and Indemnity
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:riskManagement S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk-Based Quality Management
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:dataGovernance S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Governance
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:dataProtection S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Protection
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:sourceData S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Source Data
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:protcolDeviations S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Deviations
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:earlySiteClosure S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Early Site Closure
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:decisionRights S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Decision Rights for Site Closure
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:criteria S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Crteria for Early Closure
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
........ section:responsibilities S 1..1 BackboneElement Nested Section
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Responsibilities Following Early Site Closure
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:dataDissemination S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Dissemination
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:definitions SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Supporting Details
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:clinicalLaboratoryTests S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Tests
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:regional S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Country/Region-Specific Differences
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section:priorAmendments S 1..1 BackboneElement Nested Section
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prior Protocol Amendment(s)
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section:glossary SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Glossary of Terms and Abbreviations
..... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(ValueSet | CodeSystem) A reference to data that supports this section
.... section:references SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: References
..... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(Citation) A reference to data that supports this section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.statusrequiredCompositionStatus
http://hl7.org/fhir/ValueSet/composition-status|6.0.0-ballot3
From the FHIR Standard
Composition.typepreferredFHIRDocumentTypeCodes
http://hl7.org/fhir/ValueSet/doc-typecodes
From the FHIR Standard
Composition.relatesTo.typerequiredArtifactRelationshipType
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:citeAs.typerequiredPattern Value: cite-as
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:partOf.typerequiredPattern Value: part-of
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:derivedFrom.typerequiredPattern Value: derived-from
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:specificationOf.typerequiredPattern Value: specification-of
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:dependsOn.typerequiredPattern Value: depends-on
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:supportedWith.typerequiredPattern Value: supported-with
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.section, Composition.section:titlepage, Composition.section:summary, Composition.section:introduction, Composition.section:estimands, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:definitions, Composition.section:glossary, Composition.section:referencesA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.section, Composition.section:titlepage, Composition.section:summary, Composition.section:introduction, Composition.section:estimands, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:definitions, Composition.section:glossary, Composition.section:referencesA section can only have an emptyReason if no entries are included
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4errorCompositionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from EvidenceReport

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* EvidenceReport A set of resources composed into a single coherent clinical statement with clinical attestation
... type
.... coding 1..1 Coding Code defined by a terminology system
Required Pattern: At least the following
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 35528-9
..... display 1..1 string Representation defined by the system
Fixed Value: Clinical trial protocol Clinical trial protocol
.... text 0..1 string Plain text representation of the concept
Required Pattern: CeSHarP Report
... Slices for section 15..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code.text
.... section:titlepage S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Title Page
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section0-title-page
..... entry 0..* Reference(StudyDesign) A reference to data that supports this section
.... section:summary S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Summary
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section1-protocol-summary
..... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:protocolSynopsis S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Synopsis
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.1-protocol-synopsis
....... Slices for section 6..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:objectivesEndpoints S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Primary and Secondary Objectives and Estimands
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section1.1.1-objectives-estimands
......... text 1..1 Narrative Text summary of the section, for human interpretation
......... entry 0..* Reference(Composition) A reference to data that supports this section
........ section:overallDesign 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Design
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section1.1.2-overall-design
......... text 1..1 Narrative Text summary of the section, for human interpretation
......... entry 0..* Reference(Composition | ResearchStudy) A reference to data that supports this section
........ section:numberOfArms 1..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Number of Arms
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:blinding 1..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Blinding
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:numberOfParticipants 1..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Number of Participants
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:duration 0..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Duration
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:committees 1..1 BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Committees
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:trialSchema S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Schema
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.2-trial-schema
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
...... section:scheduleOfActivities S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Schedule of Activities
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.3-schedule-of-activities
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
.... section:introduction S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Introduction
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section2-introduction
..... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:purposeOfTrial S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Purpose of Trial
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section2.1-trial-purpose
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:benefitsAndRisks S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assessment of Risks and Benefits
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2-benefits-risks
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:riskSummary 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk Summary and Mitigation Strategy
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1-risk-summary
......... text 0..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:trialIntervention S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Intervention Risks and Mitigations
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.1-trial-intervention-risk-summary
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:trialProcedures 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Procedure Risks and Mitigations
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.2-trial-procedures-risk-summary
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:otherRisk 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Other Risks and Mitigations
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.3-trial-other-risk-summary
........... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:benefitSummary S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Benefit Summary
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.2-benefit-summary
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:overallBenefitRisk 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Risk-Benefit Assessment
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.3-overall-benefit-risk-conclusion
......... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:estimands S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Objectives and Associated Estimands
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section3-estimands
..... entry 0..* Reference(StudyDesign) A reference to data that supports this section
.... section:design S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Design
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section4-trial-design
..... Slices for section 4..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:description S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Design
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.1-description-of-trial-design
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:stakeholderInput S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Stakeholder Input into Design
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.1.1-stakeholder-input-into-design
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:rationale S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Trial Design
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.2-rationale-for-trial-design
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:endpoints S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Estimand(s)
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.1-rationale-estimands
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:model S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Intervention Model
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.2-rationale-intervention-model
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:comparator S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Control Type
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.3-rationale-comparator
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:duration S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Duration
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.4-rationale-duration
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:adaptive S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Adaptive or Novel Trial Design
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.5-rationale-adaptive
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:interim S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Interim Analysis
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.6-rationale-interim-analysis
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:otherAspects S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Other Trial Design Aspects
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.7-rationale-other-aspects
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:trialStoppingRules S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Stopping Rules
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.3-trial-stopping-rules
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:startEnd S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Start of Trial and End of Trial
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.4-start-and-end
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:access S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Access to Trial Intervention After End of Trial
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.5-access-after-trial
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:population S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Population
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section5-trial-population
..... Slices for section 6..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:description S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Population and Rationale
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.1-population-description
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:inclusionCriteria S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Inclusion Criteria
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.2-inclusion-criteria
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:exclusionCriteria S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Exclusion Criteria
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.3-exclusion-criteria
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(CohortDefinition) A reference to data that supports this section
...... section:contraception S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.4-contraception
....... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:contraceptionDefinitions S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions Related to Childbearing Potential
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.4.1-contraception-definitions
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:contraceptionDetails S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception Requirements
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.4.2-contraception-details
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:lifestyle S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Lifestyle Restrictions
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.5-lifestyle-restrictions
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:dietary S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Meals and Dietary Restrictions
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.1-dietary-restrictions
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:substances S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.2-substances-restrictions
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:activity S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Activity Restrictions
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.3-activity-restrictions
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:other S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Activity Restrictions
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.4-other-restrictions
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:screenFailures S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screen Failure and Rescreening
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.6-screen-failure
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:intervention S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Intervention and Concomitant Therapy
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section6-trial-intervention
..... text 0..1 Narrative Text summary of the section, for human interpretation
..... Slices for section 9..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:description S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Investigational Trial Intervention
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.1-description-of-trial-intervention
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
...... section:rationale S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.2-rationale-for-trial-intervention-regimen
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
...... section:dosingAdministration S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Administration
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.3-dosing-and-administration
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ActivityDefinition) A reference to data that supports this section
...... section:doseModification S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Dose Modification
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.4-dose-modification
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ActivityDefinition) A reference to data that supports this section
...... section:treatmentOfOverdose S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Investigational Trial Intervention Overdose
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.5-management-of-overdose
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(ActivityDefinition | PlanDefinition) A reference to data that supports this section
...... section:preparation S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.6-preparation-storage-handling
....... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:preparationIntervention S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation of Investigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.1-preparation
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:storageHandling S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Storage and Handling of Investigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.2-storage-handling
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:accountability S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Accountability of Investigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.3-accountability
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:assignmentAndBlinding S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.7-assignment-randomisation-blinding
....... Slices for section 4..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:assignment S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Assignment to Investigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.1-assignment
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:randomisation S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Randomisation
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.2-randomisation
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:blinding S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Measures to Maintain Blinding
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.3-blinding
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:unblinding S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Unblinding at the Site
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.4-unblinding
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:adherence S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Adherence
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.8-intervention-adherence
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:noninvestigationalTherapy S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Non-Investigational Trial Intervention
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.9-noninvestigational-interventions
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:background S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Background Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.1-background-intervention
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:rescue S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rescue Therapy
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.2-rescue-therapy
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:other S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Noninvestigational Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.3-other-therapy
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:concomitantTherapy S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Concomitant Therapy
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.10-concomitant-therapy
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:prohibited S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prohibited Concomitant Therapy
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.10.1-prohibited-concomitant-therapy
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:permitted S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permitted Concomitant Therapy
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.10.2-permitted-concomitant-therapy
......... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:dropout S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section7-participant-discontinuation
..... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:discontinuation S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation of Trial Intervention for Individual Participants
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.1-discontinuation-of-trial-intervention
....... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:permanent S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permanent Discontinuation of Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.1-permanent-discontinuation-of-trial-intervention
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:temporary S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Temporary Discontinuation of Trial Intervention
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.2-temporary-discontinuation-of-trial-intervention
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:rechallenge S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rechallenge
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.3-rechallenge
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:withdrawal S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation or Withdrawal from the Trial
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.2-participant-withdrawal
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:lostToFollowUp S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Loss to Follow-Up
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.3-lost-to-follow-up
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:assessments S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
..... Slices for section 8..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:considerations S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures Considerations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.1-assessments-procedures
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:screeningBaseline S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screening/Baseline Assessments and Procedures
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.2-screening-baseline-assessments
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:efficacy S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Efficacy Assessments and Procedures
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.3-efficacy-assessments
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:safety S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Assessments and Procedures
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.4-safety-assessments
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:physical S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Examination
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.1-physical-examination
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:vitals S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Vital Signs
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.2-vital-signs
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:ecg S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Electrocardiograms
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.3-electrocardiograms
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:laboratory S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Assessments
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.4-clinical-laboratory-assessments
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:pregnancy S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy Testing
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.5-pregnancy-testing
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:suicidal S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.6-suicidal-ideation
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:pharmacokinetics S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacokinetics
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.5-pharmacokinetics
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:biomarkers S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Biomarkers
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.6-biomarkers
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:genetics S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Genetics and Pharmacogenomics
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.1-genetics-pharmacogenomics
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:pharmacodynamics S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacodynamic Biomarkers
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.2-pharmacodynamics
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:other S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Biomarkers
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.3-other-biomarkers
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:immunogenicity S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Immunogenicity Assessments
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.7-immunogenicity-assessments
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:economics S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Medical Resource Utilisation and Health Economics
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.8-economics
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:adverseEvents S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events, Serious Adverse Events, Product Complaints, Pregnancy and Postpartum Information, and Special Safety Situations
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section9-adverse-events
..... Slices for section 4..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:definitions S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.1-definitions
....... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:adverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Adverse Events
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.1-definitions-adverse-events
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:seriousAdverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Serious Adverse Events
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.2-definitions-serious-adverse-events
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:productComplaintsDefinitions S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Product Complaints
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.3-definitions-product-complaints
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:collectionMethods S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing and Procedures for Collection and Reporting
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2-collection-methods
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 5..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:timing 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.1-timing
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:procedures 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Collection Procedures
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2-collection-procedures
......... text 1..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 5..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:identifying 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Identification
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.1-identification
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:intensity 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Severity
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.2-severity
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:causality 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Causality
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.3-causality
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:recording 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Recording
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.4-recording
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:followup 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Follow-up
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.5-followup
........... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:reporting 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Reporting
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.3-reporting-events
......... text 1..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 1..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:regulatoryRequirements 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory Reporting Requirements
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.3.1-regulatory-requirements
........... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:specialInterest 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events of Special Interest
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.4-special-interest
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:diseaseRelatedEvents 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.5-disease-related-events
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:pregnancy S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy and Postpartum Information
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.3-pregnancy-postpartum
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:pregnant S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Who Become Pregnant During the Trial
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.3.1-pregnant
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:pregnantPartner S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Whose Partners Become Pregnant
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.3.2-pregnant-partner
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:special S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Special Safety Situations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.4-special-safety-situations
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:statistics S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Considerations
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section10-statistics
..... text 0..1 Narrative Text summary of the section, for human interpretation
..... Slices for section 6..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:considerations S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: General Considerations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.1-general-considerations
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:analysisSets S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analysis Sets
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.2-analysis-sets
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:analysisBaseline S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses of Demographics and Other Baseline Variables
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.3-analyses-demographics
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:analysisPrimaryObjective S 1..* BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Primary Objective(s)
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4-analysis-primary-objective
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 1..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:analysisPrimaryInstance S 1..* BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1-analysis-primary-objective-instance
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text 0..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:statisticalModel S 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.1-statistical-method
........... text 1..1 Narrative Text summary of the section, for human interpretation
........... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Primary Estimand(s)
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.2-data-handling
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:missingData S 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.3-missing-data-handling
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:sensitvityAnalysis S 1..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.4-sensitivity-analysis
........... text 1..1 Narrative Text summary of the section, for human interpretation
........... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.5-supplementary-analysis
........... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:secondaryAnalysis S 0..* BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Secondary Objective(s)
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5-analysis-secondary-objective
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 1..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:analysisSecondaryInstance S 1..* BackboneElement Nested Section
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1-analysis-secondary-objective-instance
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text 0..1 Narrative Text summary of the section, for human interpretation
......... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
.......... section:statisticalModel S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.1-statistical-method
........... text 1..1 Narrative Text summary of the section, for human interpretation
........... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.2-data-handling
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:missingData S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.3-missing-data-handling
........... text 1..1 Narrative Text summary of the section, for human interpretation
.......... section:sensitvityAnalysis S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.4-sensitivity-analysis
........... text 1..1 Narrative Text summary of the section, for human interpretation
........... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... code
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.5-supplementary-analysis
........... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:exploratoryAnalysis S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Exploratory Objective(s)
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.6-analysis-exploratory-objective
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:safetyAnalyses S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Analyses
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.7-safety-analyses
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:otherAnalyses S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Analyses
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.8-other-analyses
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:multiplicity S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Multiplicity Adjustments
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.10-multiplicity-adjustments
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:interimAnalyses S 0..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Interim Analyses
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.9-interim-analyses
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:sampleSize S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sample Size Determination
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.11-sample-size-determination
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... entry 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
.... section:oversight S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight and Other General Considerations
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section11-oversight
..... Slices for section 12..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:regulatory S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory and Ethical Considerations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.1-regulatory-considerations
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:trialOversight S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.2-trial-oversight
....... text 0..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 2..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:investigatorResponsibilities S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigator Responsibilities
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.2.1-investigator-responsibilities
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:sponsorResponsibilities S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sponsor Responsibilities
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.2.2-sponsor-responsibilities
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:committees S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Committees
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.4-committees
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:informedConsent S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent Process
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.3-informed-consent-process
....... text 1..1 Narrative Text summary of the section, for human interpretation
....... Slices for section 0..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:assentProcess S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assent Process
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.0-assent-process
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:emergency S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Consent Process
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.0-emergency-consent-process
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:rescreening S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Rescreening
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.1-rescreening-consent-process
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:remainingSamples S 0..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.2-remaining-samples
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:insurance S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Insurance and Indemnity
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.5-insurance-and-indemnity
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:riskManagement S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk-Based Quality Management
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.6-risk-management
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:dataGovernance S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Governance
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.7-data-governance
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:dataProtection S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Protection
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.8-data-protection
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:sourceData S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Source Data
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.9-source-data
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:protcolDeviations S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Deviations
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.10-protocol-deviations
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:earlySiteClosure S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Early Site Closure
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure
....... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
........ section:decisionRights S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Decision Rights for Site Closure
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#decisionRights
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:criteria S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Crteria for Early Closure
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#criteria
......... text 1..1 Narrative Text summary of the section, for human interpretation
........ section:responsibilities S 1..1 BackboneElement Nested Section
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Responsibilities Following Early Site Closure
......... code
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#responsibilities
......... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:dataDissemination S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Dissemination
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.12-data-dissemination
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:definitions S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Supporting Details
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section12-supporting-details
..... Slices for section 3..* Nested Section
Slice: Unordered, Open by value:code.text
...... section:clinicalLaboratoryTests S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Tests
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.1-clinical-laboratory-tests
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:regional S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Country/Region-Specific Differences
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.2-country-specific-differences
....... text 1..1 Narrative Text summary of the section, for human interpretation
...... section:priorAmendments S 1..1 BackboneElement Nested Section
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prior Protocol Amendment(s)
....... code
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.3-prior-protocol-amendments
....... text 1..1 Narrative Text summary of the section, for human interpretation
.... section:glossary S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Glossary of Terms and Abbreviations
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section13-glossary
..... text 1..1 Narrative Text summary of the section, for human interpretation
..... entry 0..* Reference(ValueSet | CodeSystem) A reference to data that supports this section
.... section:references S 1..1 BackboneElement Composition is broken into sections
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: References
..... code
...... text 1..1 string Plain text representation of the concept
Required Pattern: section14-references
..... text 1..1 Narrative Text summary of the section, for human interpretation
..... entry 0..* Reference(Citation) A reference to data that supports this section

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* EvidenceReport A set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:versionAlgorithm 0..1 Coding How to compare versions
URL: http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
Binding: VersionAlgorithm (extensible)
.... extension:experimental 0..1 boolean For testing purposes, not real usage
URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental
.... extension:description 0..1 markdown Natural language description of the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-description
.... extension:purpose 0..1 markdown Why this artifact is defined
URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose
.... extension:copyright 0..1 markdown Use and/or publishing restrictions
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright
.... extension:copyrightLabel 0..1 string Copyright holder and year(s)
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel
.... extension:approvalDate 0..1 date When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-approvalDate
.... extension:lastReviewDate 0..1 date When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-lastReviewDate
.... extension:effectivePeriod 0..1 Period When the artifact is expected to be used
URL: http://hl7.org/fhir/StructureDefinition/artifact-effectivePeriod
.... extension:additionalLanguage 0..* code The additional language
URL: http://hl7.org/fhir/StructureDefinition/additional-language
Binding: AllLanguages (required): IETF language tag for a human language
.... extension:extendedContactDetail 0..* ExtendedContactDetail Contact details for the publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-extended-contact-detail
.... extension:publicationDate 0..1 date Publication date of Resource
URL: http://hl7.org/fhir/StructureDefinition/artifact-publicationDate
.... extension:publicationStatus 0..1 CodeableConcept Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url Σ 0..1 uri Canonical identifier for this Composition, represented as a URI (globally unique)
... identifier Σ 0..* Identifier Version-independent identifier for the Composition
... version Σ 0..1 string An explicitly assigned identifier of a variation of the content in the Composition
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding 1..1 Coding Code defined by a terminology system

Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 35528-9
..... display 1..1 string Representation defined by the system
Fixed Value: Clinical trial protocol Clinical trial protocol
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
Required Pattern: CeSHarP Report
... category Σ 0..* CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
... subject Σ 0..* Reference(Resource) Who and/or what the composition is about
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Composition editing time
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author Σ 1..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the composition
... name Σ 0..1 string Name for this Composition (computer friendly)
... title Σ 1..1 string Human Readable name/title
... note 0..* Annotation For any additional notes
... attester 0..* BackboneElement Attests to accuracy of composition
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... mode 1..1 CodeableConcept reviewer | editor | endorser | informant | recorder
Binding: Contributor Role (preferred)
.... time 0..1 dateTime When the composition was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) Who attested the composition
... custodian Σ 0..1 Reference(Organization) Organization which maintains the composition
... Slices for relatesTo 0..* BackboneElement Relationships to other compositions/documents
Slice: Unordered, Open by value:type
.... relatesTo:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:citeAs 0..1 BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: cite-as
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:partOf 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: part-of
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:derivedFrom 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: derived-from
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:specificationOf 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: specification-of
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:dependsOn 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: depends-on
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
.... relatesTo:supportedWith 0..* BackboneElement Relationships to other compositions/documents
..... id 0..1 string Unique id for inter-element referencing
..... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
...... extension:classifier 0..1 CodeableConcept Additional classifiers for RelatedArtifacts
URL: http://hl7.org/fhir/StructureDefinition/relatesto-classifier
Binding: CitationArtifactClassifier (example): Additional classifiers for the related artifact.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 1..1 code documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): The type of relationship to the related artifact.
Required Pattern: supported-with
..... target[x] 1..1 The artifact that is related to this Composition
...... targetUri uri
...... targetAttachment Attachment
...... targetCanonical canonical(Resource)
...... targetReference Reference(Resource)
...... targetMarkdown markdown
... event Σ 0..* BackboneElement The clinical service(s) being documented
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... period Σ 0..1 Period The period covered by the documentation
.... detail Σ 0..* CodeableReference(Resource) The event(s) being documented, as code(s), reference(s), or both
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
... Slices for section C 15..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code.text
Constraints: cmp-1, cmp-2
.... section:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section
.... section:titlepage SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Title Page
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section0-title-page
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(StudyDesign) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section
.... section:summary SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Summary
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section1-protocol-summary
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:protocolSynopsis S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Synopsis
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.1-protocol-synopsis
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:objectivesEndpoints S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Primary and Secondary Objectives and Estimands
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section1.1.1-objectives-estimands
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Composition) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:overallDesign 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Design
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section1.1.2-overall-design
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Composition | ResearchStudy) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:numberOfArms 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Number of Arms
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:blinding 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Blinding
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:numberOfParticipants 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Number of Participants
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:duration 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Duration
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:committees 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: Committees
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:trialSchema S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Schema
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.2-trial-schema
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:scheduleOfActivities S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Schedule of Activities
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section1.3-schedule-of-activities
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(SoaPlanDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:introduction SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Introduction
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section2-introduction
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:purposeOfTrial S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Purpose of Trial
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section2.1-trial-purpose
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:benefitsAndRisks S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assessment of Risks and Benefits
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2-benefits-risks
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:riskSummary 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk Summary and Mitigation Strategy
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1-risk-summary
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:trialIntervention S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Intervention Risks and Mitigations
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.1-trial-intervention-risk-summary
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:trialProcedures 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Procedure Risks and Mitigations
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.2-trial-procedures-risk-summary
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:otherRisk 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial-specific Other Risks and Mitigations
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.1.3-trial-other-risk-summary
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
........ section:benefitSummary S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Benefit Summary
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.2-benefit-summary
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:overallBenefitRisk 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Overall Risk-Benefit Assessment
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section2.2.3-overall-benefit-risk-conclusion
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
.... section:estimands SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Objectives and Associated Estimands
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section3-estimands
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(StudyDesign) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section
.... section:design SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Design
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section4-trial-design
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:description S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Design
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.1-description-of-trial-design
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:stakeholderInput S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Stakeholder Input into Design
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.1.1-stakeholder-input-into-design
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:rationale S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Trial Design
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.2-rationale-for-trial-design
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:endpoints S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Estimand(s)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.1-rationale-estimands
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:model S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Intervention Model
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.2-rationale-intervention-model
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:comparator S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Control Type
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.3-rationale-comparator
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:duration S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Duration
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.4-rationale-duration
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:adaptive S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Adaptive or Novel Trial Design
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.5-rationale-adaptive
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:interim S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Interim Analysis
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.6-rationale-interim-analysis
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:otherAspects S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Other Trial Design Aspects
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section4.2.7-rationale-other-aspects
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:trialStoppingRules S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Stopping Rules
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.3-trial-stopping-rules
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:startEnd S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Start of Trial and End of Trial
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.4-start-and-end
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:access S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Access to Trial Intervention After End of Trial
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section4.5-access-after-trial
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:population SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Population
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section5-trial-population
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:description S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Trial Population and Rationale
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.1-population-description
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:inclusionCriteria S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Inclusion Criteria
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.2-inclusion-criteria
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:exclusionCriteria S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Exclusion Criteria
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.3-exclusion-criteria
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(CohortDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:contraception S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.4-contraception
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:contraceptionDefinitions S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions Related to Childbearing Potential
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.4.1-contraception-definitions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:contraceptionDetails S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Contraception Requirements
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.4.2-contraception-details
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:lifestyle S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Lifestyle Restrictions
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.5-lifestyle-restrictions
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:dietary S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Meals and Dietary Restrictions
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.1-dietary-restrictions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:substances S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Caffeine, Alcohol, Tobacco, and Other Restrictions
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.2-substances-restrictions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:activity S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Activity Restrictions
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.3-activity-restrictions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:other S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Activity Restrictions
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section5.5.4-other-restrictions
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:screenFailures S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screen Failure and Rescreening
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section5.6-screen-failure
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:intervention SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Intervention and Concomitant Therapy
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section6-trial-intervention
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 9..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:description S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Description of Investigational Trial Intervention
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.1-description-of-trial-intervention
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:rationale S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rationale for Investigational Trial Intervention Dose and Regimen
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.2-rationale-for-trial-intervention-regimen
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ConceptualExposureDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:dosingAdministration S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Administration
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.3-dosing-and-administration
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ActivityDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:doseModification S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Dose Modification
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.4-dose-modification
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ActivityDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:treatmentOfOverdose S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Investigational Trial Intervention Overdose
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.5-management-of-overdose
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(ActivityDefinition | PlanDefinition) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:preparation S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.6-preparation-storage-handling
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:preparationIntervention S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Preparation of Investigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.1-preparation
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:storageHandling S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Storage and Handling of Investigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.2-storage-handling
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:accountability S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Accountability of Investigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.6.3-accountability
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:assignmentAndBlinding S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Assignment, Randomisation and Blinding
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.7-assignment-randomisation-blinding
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:assignment S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Assignment to Investigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.1-assignment
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:randomisation S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Randomisation
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.2-randomisation
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:blinding S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Measures to Maintain Blinding
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.3-blinding
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:unblinding S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Unblinding at the Site
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.7.4-unblinding
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:adherence S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigational Trial Intervention Adherence
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.8-intervention-adherence
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:noninvestigationalTherapy S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Non-Investigational Trial Intervention
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.9-noninvestigational-interventions
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:background S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Background Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.1-background-intervention
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:rescue S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rescue Therapy
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.2-rescue-therapy
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:other S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Noninvestigational Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.9.3-other-therapy
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:concomitantTherapy S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Concomitant Therapy
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section6.10-concomitant-therapy
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:prohibited S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prohibited Concomitant Therapy
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.10.1-prohibited-concomitant-therapy
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:permitted S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permitted Concomitant Therapy
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section6.10.2-permitted-concomitant-therapy
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
.... section:dropout SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section7-participant-discontinuation
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:discontinuation S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation of Trial Intervention for Individual Participants
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.1-discontinuation-of-trial-intervention
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:permanent S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Permanent Discontinuation of Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.1-permanent-discontinuation-of-trial-intervention
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:temporary S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Temporary Discontinuation of Trial Intervention
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.2-temporary-discontinuation-of-trial-intervention
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:rechallenge S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Rechallenge
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section7.1.3-rechallenge
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:withdrawal S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Discontinuation or Withdrawal from the Trial
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.2-participant-withdrawal
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:lostToFollowUp S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Management of Loss to Follow-Up
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section7.3-lost-to-follow-up
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:assessments SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 8..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:considerations S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Assessments and Procedures Considerations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.1-assessments-procedures
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:screeningBaseline S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Screening/Baseline Assessments and Procedures
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.2-screening-baseline-assessments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:efficacy S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Efficacy Assessments and Procedures
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.3-efficacy-assessments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:safety S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Assessments and Procedures
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.4-safety-assessments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:physical S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Physical Examination
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.1-physical-examination
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:vitals S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Vital Signs
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.2-vital-signs
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:ecg S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Electrocardiograms
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.3-electrocardiograms
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:laboratory S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Assessments
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.4-clinical-laboratory-assessments
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:pregnancy S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy Testing
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.5-pregnancy-testing
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:suicidal S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Suicidal Ideation and Behaviour Risk Monitoring
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.4.6-suicidal-ideation
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:pharmacokinetics S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacokinetics
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.5-pharmacokinetics
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:biomarkers S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Biomarkers
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.6-biomarkers
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:genetics S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Genetics and Pharmacogenomics
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.1-genetics-pharmacogenomics
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:pharmacodynamics S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pharmacodynamic Biomarkers
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.2-pharmacodynamics
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:other S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Biomarkers
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section8.6.3-other-biomarkers
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:immunogenicity S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Immunogenicity Assessments
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.7-immunogenicity-assessments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:economics S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Medical Resource Utilisation and Health Economics
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section8.8-economics
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:adverseEvents SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events, Serious Adverse Events, Product Complaints, Pregnancy and Postpartum Information, and Special Safety Situations
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section9-adverse-events
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 4..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:definitions S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.1-definitions
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:adverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Adverse Events
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.1-definitions-adverse-events
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:seriousAdverseEventsDefinitions S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Serious Adverse Events
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.2-definitions-serious-adverse-events
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:productComplaintsDefinitions S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Definitions of Product Complaints
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.1.3-definitions-product-complaints
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:collectionMethods S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing and Procedures for Collection and Reporting
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2-collection-methods
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 5..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:timing 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Timing
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.1-timing
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:procedures 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Collection Procedures
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2-collection-procedures
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 5..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:identifying 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Identification
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.1-identification
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:intensity 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Severity
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.2-severity
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:causality 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Causality
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.3-causality
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:recording 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Recording
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.4-recording
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:followup 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Follow-up
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.2.5-followup
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
........ section:reporting 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Reporting
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.3-reporting-events
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:regulatoryRequirements 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory Reporting Requirements
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.3.1-regulatory-requirements
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
........ section:specialInterest 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Adverse Events of Special Interest
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.4-special-interest
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:diseaseRelatedEvents 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.2.5-disease-related-events
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:pregnancy S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Pregnancy and Postpartum Information
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.3-pregnancy-postpartum
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:pregnant S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Who Become Pregnant During the Trial
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.3.1-pregnant
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:pregnantPartner S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Participants Whose Partners Become Pregnant
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section9.3.2-pregnant-partner
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:special S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Special Safety Situations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section9.4-special-safety-situations
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:statistics SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Considerations
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section10-statistics
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 6..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:considerations S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: General Considerations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.1-general-considerations
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:analysisSets S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analysis Sets
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.2-analysis-sets
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:analysisBaseline S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses of Demographics and Other Baseline Variables
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.3-analyses-demographics
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:analysisPrimaryObjective S 1..* BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Primary Objective(s)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4-analysis-primary-objective
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:analysisPrimaryInstance S 1..* BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1-analysis-primary-objective-instance
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:statisticalModel S 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.1-statistical-method
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Primary Estimand(s)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.2-data-handling
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:missingData S 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.3-missing-data-handling
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:sensitvityAnalysis S 1..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.4-sensitivity-analysis
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.4.1.5-supplementary-analysis
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
...... section:secondaryAnalysis S 0..* BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Secondary Objective(s)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5-analysis-secondary-objective
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 1..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:analysisSecondaryInstance S 1..* BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1-analysis-secondary-objective-instance
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(VariableDefinition) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
.......... section:All Slices Content/Rules for all slices
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:statisticalModel S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Statistical Analysis Method
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.1-statistical-method
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:intercurrentEventHandling S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.2-data-handling
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:missingData S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.3-missing-data-handling
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:sensitvityAnalysis S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sensitivity Analysis
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.4-sensitivity-analysis
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
.......... section:supplementaryAnalysis S 0..1 BackboneElement Nested Section
........... id 0..1 string Unique id for inter-element referencing
........... extension 0..* Extension Additional content defined by implementations
........... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Supplementary Analysis
........... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
............ id 0..1 id Unique id for inter-element referencing
............ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
............ coding 0..* Coding Code defined by a terminology system
............ text 1..1 string Plain text representation of the concept
Required Pattern: section10.5.1.5-supplementary-analysis
........... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
........... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
........... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
........... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
........... entry C 0..* Reference(Resource) A reference to data that supports this section
........... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
........... section 0..* See section (Composition) Nested Section
...... section:exploratoryAnalysis S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Analyses Associated with the Exploratory Objective(s)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.6-analysis-exploratory-objective
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:safetyAnalyses S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Safety Analyses
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.7-safety-analyses
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:otherAnalyses S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Other Analyses
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.8-other-analyses
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:multiplicity S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Multiplicity Adjustments
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.10-multiplicity-adjustments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:interimAnalyses S 0..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Interim Analyses
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.9-interim-analyses
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:sampleSize S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sample Size Determination
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section10.11-sample-size-determination
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(EndpointAnalysisPlan) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:oversight SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight and Other General Considerations
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section11-oversight
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 12..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:regulatory S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Regulatory and Ethical Considerations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.1-regulatory-considerations
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:trialOversight S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Trial Oversight
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.2-trial-oversight
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 2..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:investigatorResponsibilities S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Investigator Responsibilities
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.2.1-investigator-responsibilities
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:sponsorResponsibilities S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Sponsor Responsibilities
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.2.2-sponsor-responsibilities
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:committees S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Committees
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.4-committees
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:informedConsent S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent Process
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.3-informed-consent-process
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 0..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:assentProcess S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Assent Process
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.0-assent-process
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:emergency S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Emergency Consent Process
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.0-emergency-consent-process
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:rescreening S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Rescreening
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.1-rescreening-consent-process
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:remainingSamples S 0..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Informed Consent for Remaining Samples in Exploratory Research
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.3.2-remaining-samples
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:insurance S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Insurance and Indemnity
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.5-insurance-and-indemnity
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:riskManagement S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Risk-Based Quality Management
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.6-risk-management
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:dataGovernance S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Governance
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.7-data-governance
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:dataProtection S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Protection
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.8-data-protection
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:sourceData S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Source Data
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.9-source-data
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:protcolDeviations S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Protocol Deviations
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.10-protocol-deviations
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:earlySiteClosure S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Early Site Closure
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
........ section:All Slices Content/Rules for all slices
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:decisionRights S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Decision Rights for Site Closure
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#decisionRights
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:criteria S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Crteria for Early Closure
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#criteria
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
........ section:responsibilities S 1..1 BackboneElement Nested Section
......... id 0..1 string Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
......... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
......... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Responsibilities Following Early Site Closure
......... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... coding 0..* Coding Code defined by a terminology system
.......... text 1..1 string Plain text representation of the concept
Required Pattern: section11.11-early-site-closure#responsibilities
......... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
......... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
......... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
......... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
......... entry C 0..* Reference(Resource) A reference to data that supports this section
......... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
......... section 0..* See section (Composition) Nested Section
...... section:dataDissemination S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Data Dissemination
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section11.12-data-dissemination
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:definitions SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Supporting Details
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section12-supporting-details
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... Slices for section 3..* See section (Composition) Nested Section
Slice: Unordered, Open by value:code.text
...... section:All Slices Content/Rules for all slices
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 0..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:clinicalLaboratoryTests S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Clinical Laboratory Tests
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.1-clinical-laboratory-tests
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:regional S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Country/Region-Specific Differences
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.2-country-specific-differences
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
...... section:priorAmendments S 1..1 BackboneElement Nested Section
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Prior Protocol Amendment(s)
....... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding 0..* Coding Code defined by a terminology system
........ text 1..1 string Plain text representation of the concept
Required Pattern: section12.3-prior-protocol-amendments
....... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
....... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
....... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
....... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
....... section 0..* See section (Composition) Nested Section
.... section:glossary SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: Glossary of Terms and Abbreviations
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section13-glossary
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(ValueSet | CodeSystem) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section
.... section:references SC 1..1 BackboneElement Composition is broken into sections
Constraints: cmp-1, cmp-2
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
Required Pattern: Appendix: References
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding 0..* Coding Code defined by a terminology system
...... text 1..1 string Plain text representation of the concept
Required Pattern: section14-references
..... author 0..* Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section, when the section is authored by someone other than the composition.author
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 1..1 Narrative Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Citation) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3
From the FHIR Standard
Composition.statusrequiredCompositionStatus
http://hl7.org/fhir/ValueSet/composition-status|6.0.0-ballot3
From the FHIR Standard
Composition.typepreferredFHIRDocumentTypeCodes
http://hl7.org/fhir/ValueSet/doc-typecodes
From the FHIR Standard
Composition.categoryexampleReferencedItemCategoryValueSet
http://hl7.org/fhir/ValueSet/referenced-item-category
From the FHIR Standard
Composition.attester.modepreferredContributorRole
http://terminology.hl7.org/ValueSet/contributor-role
Composition.relatesTo.typerequiredArtifactRelationshipType
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:citeAs.typerequiredPattern Value: cite-as
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:partOf.typerequiredPattern Value: part-of
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:derivedFrom.typerequiredPattern Value: derived-from
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:specificationOf.typerequiredPattern Value: specification-of
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:dependsOn.typerequiredPattern Value: depends-on
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.relatesTo:supportedWith.typerequiredPattern Value: supported-with
http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3
From the FHIR Standard
Composition.event.detailexampleActCode
http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:titlepage.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:titlepage.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:titlepage.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:summary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:summary.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:objectivesEndpoints.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:overallDesign.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:overallDesign.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:overallDesign.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfArms.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:blinding.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:blinding.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:blinding.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:numberOfParticipants.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:duration.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:duration.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:duration.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:committees.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:committees.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:protocolSynopsis.section:committees.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:trialSchema.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:trialSchema.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:trialSchema.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:summary.section:scheduleOfActivities.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:summary.section:scheduleOfActivities.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:summary.section:scheduleOfActivities.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:introduction.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:introduction.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:purposeOfTrial.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:purposeOfTrial.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:purposeOfTrial.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialIntervention.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:trialProcedures.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:riskSummary.section:otherRisk.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:benefitSummary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:introduction.section:benefitsAndRisks.section:overallBenefitRisk.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:estimands.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:estimands.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:estimands.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:design.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:design.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:description.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:description.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:description.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:description.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:description.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:description.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:description.section:stakeholderInput.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:description.section:stakeholderInput.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:description.section:stakeholderInput.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:endpoints.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:endpoints.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:endpoints.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:model.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:model.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:model.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:comparator.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:comparator.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:comparator.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:duration.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:duration.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:duration.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:adaptive.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:adaptive.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:adaptive.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:interim.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:interim.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:interim.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:rationale.section:otherAspects.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:rationale.section:otherAspects.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:rationale.section:otherAspects.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:trialStoppingRules.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:trialStoppingRules.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:trialStoppingRules.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:startEnd.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:startEnd.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:startEnd.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:design.section:access.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:design.section:access.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:design.section:access.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:population.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:population.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:description.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:description.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:description.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:inclusionCriteria.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:inclusionCriteria.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:inclusionCriteria.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:exclusionCriteria.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:exclusionCriteria.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:exclusionCriteria.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:contraception.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:contraception.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:contraception.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:contraception.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:contraception.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:contraception.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDefinitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDefinitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDefinitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDetails.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDetails.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:contraception.section:contraceptionDetails.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section:dietary.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section:dietary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section:dietary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section:substances.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section:substances.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section:substances.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section:activity.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section:activity.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section:activity.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:lifestyle.section:other.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:lifestyle.section:other.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:lifestyle.section:other.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:population.section:screenFailures.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:population.section:screenFailures.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:population.section:screenFailures.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:intervention.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:intervention.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:description.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:description.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:description.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:rationale.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:rationale.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:rationale.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:dosingAdministration.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:dosingAdministration.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:dosingAdministration.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:doseModification.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:doseModification.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:doseModification.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:treatmentOfOverdose.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:treatmentOfOverdose.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:treatmentOfOverdose.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.section:preparationIntervention.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.section:preparationIntervention.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.section:preparationIntervention.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.section:storageHandling.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.section:storageHandling.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.section:storageHandling.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:preparation.section:accountability.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:preparation.section:accountability.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:preparation.section:accountability.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:assignment.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:randomisation.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:blinding.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:assignmentAndBlinding.section:unblinding.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:adherence.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:adherence.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:adherence.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:background.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:background.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:background.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:rescue.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:other.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:other.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:noninvestigationalTherapy.section:other.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:prohibited.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:prohibited.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:prohibited.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:permitted.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:permitted.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:intervention.section:concomitantTherapy.section:permitted.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:dropout.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:dropout.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:permanent.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:permanent.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:permanent.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:temporary.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:temporary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:temporary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:rechallenge.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:rechallenge.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:discontinuation.section:rechallenge.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:withdrawal.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:withdrawal.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:withdrawal.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:dropout.section:lostToFollowUp.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:dropout.section:lostToFollowUp.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:dropout.section:lostToFollowUp.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:assessments.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:assessments.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:considerations.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:considerations.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:considerations.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:screeningBaseline.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:screeningBaseline.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:screeningBaseline.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:efficacy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:efficacy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:efficacy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:physical.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:physical.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:physical.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:vitals.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:vitals.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:vitals.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:ecg.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:ecg.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:ecg.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:laboratory.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:laboratory.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:laboratory.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:pregnancy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:pregnancy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:pregnancy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:safety.section:suicidal.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:safety.section:suicidal.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:safety.section:suicidal.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:pharmacokinetics.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:pharmacokinetics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:pharmacokinetics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:genetics.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:genetics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:genetics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:pharmacodynamics.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:pharmacodynamics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:pharmacodynamics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:other.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:other.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:biomarkers.section:other.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:immunogenicity.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:immunogenicity.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:immunogenicity.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:assessments.section:economics.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:assessments.section:economics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:assessments.section:economics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:adverseEvents.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:adverseEvents.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:adverseEventsDefinitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:seriousAdverseEventsDefinitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:definitions.section:productComplaintsDefinitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:timing.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:timing.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:timing.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:identifying.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:identifying.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:identifying.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:intensity.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:intensity.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:intensity.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:causality.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:causality.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:causality.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:recording.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:recording.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:recording.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:followup.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:followup.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:procedures.section:followup.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section:regulatoryRequirements.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section:regulatoryRequirements.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:reporting.section:regulatoryRequirements.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:specialInterest.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:specialInterest.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:specialInterest.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:diseaseRelatedEvents.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:diseaseRelatedEvents.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:collectionMethods.section:diseaseRelatedEvents.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnant.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnant.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnant.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:pregnancy.section:pregnantPartner.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:adverseEvents.section:special.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:adverseEvents.section:special.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:adverseEvents.section:special.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:statistics.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:statistics.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:considerations.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:considerations.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:considerations.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisSets.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisSets.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisSets.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisBaseline.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisBaseline.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisBaseline.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:statisticalModel.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:statisticalModel.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:statisticalModel.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:intercurrentEventHandling.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:intercurrentEventHandling.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:intercurrentEventHandling.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:missingData.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:missingData.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:missingData.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:sensitvityAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:sensitvityAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:sensitvityAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:supplementaryAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:supplementaryAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:analysisPrimaryObjective.section:analysisPrimaryInstance.section:supplementaryAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:statisticalModel.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:statisticalModel.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:statisticalModel.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:intercurrentEventHandling.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:intercurrentEventHandling.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:intercurrentEventHandling.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:missingData.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:missingData.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:missingData.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:sensitvityAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:sensitvityAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:sensitvityAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:supplementaryAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:supplementaryAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:secondaryAnalysis.section:analysisSecondaryInstance.section:supplementaryAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:exploratoryAnalysis.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:exploratoryAnalysis.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:exploratoryAnalysis.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:safetyAnalyses.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:safetyAnalyses.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:safetyAnalyses.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:otherAnalyses.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:otherAnalyses.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:otherAnalyses.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:multiplicity.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:multiplicity.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:multiplicity.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:interimAnalyses.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:interimAnalyses.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:interimAnalyses.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:statistics.section:sampleSize.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:statistics.section:sampleSize.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:statistics.section:sampleSize.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:oversight.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:oversight.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:regulatory.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:regulatory.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:regulatory.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:trialOversight.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:trialOversight.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:trialOversight.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:investigatorResponsibilities.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:trialOversight.section:sponsorResponsibilities.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:committees.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:committees.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:committees.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:assentProcess.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:assentProcess.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:assentProcess.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:emergency.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:emergency.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:emergency.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:rescreening.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:rescreening.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:rescreening.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:remainingSamples.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:remainingSamples.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:informedConsent.section:remainingSamples.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:insurance.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:insurance.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:insurance.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:riskManagement.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:riskManagement.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:riskManagement.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:dataGovernance.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:dataGovernance.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:dataGovernance.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:dataProtection.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:dataProtection.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:dataProtection.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:sourceData.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:sourceData.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:sourceData.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:protcolDeviations.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:protcolDeviations.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:protcolDeviations.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:decisionRights.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:criteria.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:criteria.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:criteria.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:earlySiteClosure.section:responsibilities.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:oversight.section:dataDissemination.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:oversight.section:dataDissemination.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:oversight.section:dataDissemination.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:definitions.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.section.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:definitions.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.section:clinicalLaboratoryTests.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:definitions.section:clinicalLaboratoryTests.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.section:clinicalLaboratoryTests.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.section:regional.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:definitions.section:regional.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.section:regional.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:definitions.section:priorAmendments.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
From the FHIR Standard
Composition.section:definitions.section:priorAmendments.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:definitions.section:priorAmendments.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:glossary.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:glossary.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:glossary.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard
Composition.section:references.codeextensibleEvidenceReportSectionCode_Value_Set
https://fevir.net/resources/ValueSet/179431
From this IG
Composition.section:references.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
From the FHIR Standard
Composition.section:references.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.section, Composition.section:titlepage, Composition.section:summary, Composition.section:introduction, Composition.section:estimands, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:definitions, Composition.section:glossary, Composition.section:referencesA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.section, Composition.section:titlepage, Composition.section:summary, Composition.section:introduction, Composition.section:estimands, Composition.section:design, Composition.section:population, Composition.section:intervention, Composition.section:dropout, Composition.section:assessments, Composition.section:adverseEvents, Composition.section:statistics, Composition.section:oversight, Composition.section:definitions, Composition.section:glossary, Composition.section:referencesA section can only have an emptyReason if no entries are included
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4errorCompositionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from EvidenceReport

Summary

Mandatory: 205 elements(225 nested mandatory elements)
Must-Support: 149 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Composition.section
  • The element 1 is sliced based on the value of Composition.section.section
  • The element 1 is sliced based on the value of Composition.section.section.section
  • The element 1 is sliced based on the value of Composition.section.section.section.section

Maturity: 1

 

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