Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - 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-ballot3 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: M11ReportSection08

Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-08 Version: 1.0.0-ballot3
Standards status: Trial-use Maturity Level: 1 Computable Name: M11ReportSection08
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.148

Copyright/Legal: This Profile is developed to support 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 M11ReportSection08 Profile is used for section 8 (Trial Assessments) for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

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 resource approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/resource-approvalDate
.... extension:lastReviewDate 0..1 date Last review date for the resource
URL: http://hl7.org/fhir/StructureDefinition/resource-lastReviewDate
.... extension:effectivePeriod 0..1 Period The effective date range for the resource
URL: http://hl7.org/fhir/StructureDefinition/resource-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
... Slices for category Σ 0..* CodeableConcept Categorization of Composition
Slice: Unordered, Open by value:text
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
.... category:assessments Σ 0..1 CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
..... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
...... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
... 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
.... relatesTo:similarTo 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: similar-to
..... 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 1..1 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: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
..... 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 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Composition.status Base required Composition Status 📍6.0.0-ballot3 FHIR Std.
Composition.type Base preferred FHIR Document Type Codes 📍6.0.0-ballot3 FHIR Std.
Composition.category Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
Composition.category:assessments Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:citeAs.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:partOf.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:derivedFrom.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:specificationOf.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:dependsOn.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:supportedWith.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:similarTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cmp-1 error Composition.section, Composition.section:assessments A section must contain at least one of text, entries, or sub-sections text.exists() or entry.exists() or section.exists()
cmp-2 error Composition.section, Composition.section:assessments A section can only have an emptyReason if no entries are included emptyReason.empty() or entry.empty()
dom-2 error Composition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Composition If 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-4 error Composition If 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-5 error Composition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Composition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

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 category 0..* CodeableConcept Categorization of Composition
Slice: Unordered, Open by value:text
.... category:assessments 0..1 CodeableConcept Categorization of Composition
..... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
...... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
..... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
... Slices for section 1..1 BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code.text
.... 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
...... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
....... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
...... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
..... text 0..1 Narrative Text summary of the section, for human interpretation
..... 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218591
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218592
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218593
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218594
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4 Safety Assessments and Procedures
........ 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218595
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.1 Physical Examination
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218596
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.2 Vital Signs
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218597
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.3 Electrocardiograms
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218598
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218599
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.5 Pregnancy Testing
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218600
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
.......... 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218601
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.5 Pharmacokinetics
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218602
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6 Biomarkers
........ 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218603
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218604
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218605
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.3 Other Biomarkers
.......... 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218606
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.7 Immunogenicity Assessments
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218607
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics
........ 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

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 resource approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/resource-approvalDate
.... extension:lastReviewDate 0..1 date Last review date for the resource
URL: http://hl7.org/fhir/StructureDefinition/resource-lastReviewDate
.... extension:effectivePeriod 0..1 Period The effective date range for the resource
URL: http://hl7.org/fhir/StructureDefinition/resource-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
... Slices for category Σ 0..* CodeableConcept Categorization of Composition
Slice: Unordered, Open by value:text
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
.... category:assessments Σ 0..1 CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
..... id 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
...... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
... 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
.... relatesTo:similarTo 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: similar-to
..... 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 1..1 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: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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
....... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218591
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218592
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218593
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218594
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4 Safety Assessments and Procedures
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218595
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.1 Physical Examination
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218596
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.2 Vital Signs
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218597
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.3 Electrocardiograms
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218598
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218599
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.5 Pregnancy Testing
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218600
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218601
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.5 Pharmacokinetics
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218602
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6 Biomarkers
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218603
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218604
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218605
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.3 Other Biomarkers
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218606
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.7 Immunogenicity Assessments
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218607
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Composition.language Base required All Languages 📍6.0.0-ballot3 FHIR Std.
Composition.status Base required Composition Status 📍6.0.0-ballot3 FHIR Std.
Composition.type Base preferred FHIR Document Type Codes 📍6.0.0-ballot3 FHIR Std.
Composition.category Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
Composition.category:assessments Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
Composition.attester.​mode Base preferred Contributor Role 📦1.0.0 THO v7.1
Composition.relatesTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:citeAs.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:partOf.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:derivedFrom.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:specificationOf.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:dependsOn.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:supportedWith.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:similarTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.event.detail Base example v3 Code System ActCode 📦3.0.0 THO v7.1
Composition.section.​code Base extensible EvidenceReportSectionCode Value Set 📦1.0.0-ballot3 This IG
Composition.section.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​code Base extensible EvidenceReportSectionCode Value Set 📦1.0.0-ballot3 This IG
Composition.section:assessments.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section.code Base extensible EvidenceReportSectionCode Value Set 📦1.0.0-ballot3 This IG
Composition.section:assessments.​section.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:considerations.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:considerations.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:considerations.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:screeningBaseline.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:screeningBaseline.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:screeningBaseline.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:efficacy.code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:efficacy.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:efficacy.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:physical.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:physical.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:physical.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:vitals.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:vitals.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:vitals.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:ecg.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:ecg.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:ecg.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:laboratory.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:laboratory.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:laboratory.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:pregnancy.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:pregnancy.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:pregnancy.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:suicidal.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:suicidal.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:suicidal.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:pharmacokinetics.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:pharmacokinetics.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:pharmacokinetics.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:genetics.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:genetics.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:genetics.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:pharmacodynamics.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:pharmacodynamics.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:pharmacodynamics.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:other.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:other.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:other.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:immunogenicity.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:immunogenicity.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:immunogenicity.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:economics.code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:economics.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:economics.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cmp-1 error Composition.section, Composition.section:assessments A section must contain at least one of text, entries, or sub-sections text.exists() or entry.exists() or section.exists()
cmp-2 error Composition.section, Composition.section:assessments A section can only have an emptyReason if no entries are included emptyReason.empty() or entry.empty()
dom-2 error Composition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Composition If 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-4 error Composition If 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-5 error Composition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Composition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 17 elements(47 nested mandatory elements)
Must-Support: 18 elements

Slices

This structure defines the following Slices:

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

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 resource approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/resource-approvalDate
.... extension:lastReviewDate 0..1 date Last review date for the resource
URL: http://hl7.org/fhir/StructureDefinition/resource-lastReviewDate
.... extension:effectivePeriod 0..1 Period The effective date range for the resource
URL: http://hl7.org/fhir/StructureDefinition/resource-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
... Slices for category Σ 0..* CodeableConcept Categorization of Composition
Slice: Unordered, Open by value:text
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
.... category:assessments Σ 0..1 CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
..... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
...... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
... 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
.... relatesTo:similarTo 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: similar-to
..... 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 1..1 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: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
..... 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 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Composition.status Base required Composition Status 📍6.0.0-ballot3 FHIR Std.
Composition.type Base preferred FHIR Document Type Codes 📍6.0.0-ballot3 FHIR Std.
Composition.category Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
Composition.category:assessments Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:citeAs.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:partOf.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:derivedFrom.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:specificationOf.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:dependsOn.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:supportedWith.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:similarTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cmp-1 error Composition.section, Composition.section:assessments A section must contain at least one of text, entries, or sub-sections text.exists() or entry.exists() or section.exists()
cmp-2 error Composition.section, Composition.section:assessments A section can only have an emptyReason if no entries are included emptyReason.empty() or entry.empty()
dom-2 error Composition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Composition If 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-4 error Composition If 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-5 error Composition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Composition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

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 category 0..* CodeableConcept Categorization of Composition
Slice: Unordered, Open by value:text
.... category:assessments 0..1 CodeableConcept Categorization of Composition
..... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
...... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
..... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
... Slices for section 1..1 BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code.text
.... 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
...... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
....... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
...... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
..... text 0..1 Narrative Text summary of the section, for human interpretation
..... 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218591
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218592
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218593
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218594
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4 Safety Assessments and Procedures
........ 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218595
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.1 Physical Examination
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218596
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.2 Vital Signs
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218597
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.3 Electrocardiograms
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218598
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218599
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.5 Pregnancy Testing
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218600
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
.......... 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218601
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.5 Pharmacokinetics
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218602
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6 Biomarkers
........ 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218603
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218604
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers
.......... 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
.......... 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218605
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.3 Other Biomarkers
.......... 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218606
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.7 Immunogenicity Assessments
........ 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
........ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218607
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics
........ 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

doco Documentation for this format

Snapshot ViewView

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 resource approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/resource-approvalDate
.... extension:lastReviewDate 0..1 date Last review date for the resource
URL: http://hl7.org/fhir/StructureDefinition/resource-lastReviewDate
.... extension:effectivePeriod 0..1 Period The effective date range for the resource
URL: http://hl7.org/fhir/StructureDefinition/resource-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
... Slices for category Σ 0..* CodeableConcept Categorization of Composition
Slice: Unordered, Open by value:text
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
.... category:assessments Σ 0..1 CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
..... id 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
...... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 1..1 string Plain text representation of the concept
Required Pattern: section8-assessments
... 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
.... relatesTo:similarTo 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: similar-to
..... 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 1..1 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: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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218590
....... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218591
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218592
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218593
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218594
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4 Safety Assessments and Procedures
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218595
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.1 Physical Examination
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218596
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.2 Vital Signs
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218597
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.3 Electrocardiograms
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218598
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218599
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.5 Pregnancy Testing
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218600
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218601
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.5 Pharmacokinetics
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218602
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6 Biomarkers
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218603
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218604
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
........... version 0..1 string Version of the system - if relevant
........... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218605
........... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.3 Other Biomarkers
........... userSelected 0..1 boolean If this coding was chosen directly by the user
.......... 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218606
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.7 Immunogenicity Assessments
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
......... version 0..1 string Version of the system - if relevant
......... code 1..1 code Symbol in syntax defined by the system
Fixed Value: C218607
......... display 1..1 string Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics
......... userSelected 0..1 boolean If this coding was chosen directly by the user
........ 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Composition.language Base required All Languages 📍6.0.0-ballot3 FHIR Std.
Composition.status Base required Composition Status 📍6.0.0-ballot3 FHIR Std.
Composition.type Base preferred FHIR Document Type Codes 📍6.0.0-ballot3 FHIR Std.
Composition.category Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
Composition.category:assessments Base example Referenced Item Category Value Set 📍6.0.0-ballot3 FHIR Std.
Composition.attester.​mode Base preferred Contributor Role 📦1.0.0 THO v7.1
Composition.relatesTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:citeAs.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:partOf.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:derivedFrom.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:specificationOf.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:dependsOn.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:supportedWith.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.relatesTo:similarTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
Composition.event.detail Base example v3 Code System ActCode 📦3.0.0 THO v7.1
Composition.section.​code Base extensible EvidenceReportSectionCode Value Set 📦1.0.0-ballot3 This IG
Composition.section.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​code Base extensible EvidenceReportSectionCode Value Set 📦1.0.0-ballot3 This IG
Composition.section:assessments.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section.code Base extensible EvidenceReportSectionCode Value Set 📦1.0.0-ballot3 This IG
Composition.section:assessments.​section.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:considerations.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:considerations.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:considerations.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:screeningBaseline.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:screeningBaseline.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:screeningBaseline.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:efficacy.code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:efficacy.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:efficacy.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:physical.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:physical.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:physical.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:vitals.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:vitals.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:vitals.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:ecg.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:ecg.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:ecg.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:laboratory.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:laboratory.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:laboratory.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:pregnancy.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:pregnancy.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:pregnancy.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:suicidal.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:suicidal.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:safety.section:suicidal.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:pharmacokinetics.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:pharmacokinetics.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:pharmacokinetics.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:genetics.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:genetics.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:genetics.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:pharmacodynamics.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:pharmacodynamics.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:pharmacodynamics.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:other.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:other.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:biomarkers.section:other.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:immunogenicity.​code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:immunogenicity.​orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:immunogenicity.​emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:economics.code Base example Document Section Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:economics.orderedBy Base preferred List Order Codes 📍6.0.0-ballot3 FHIR Std.
Composition.section:assessments.​section:economics.emptyReason Base preferred List Empty Reasons 📍6.0.0-ballot3 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cmp-1 error Composition.section, Composition.section:assessments A section must contain at least one of text, entries, or sub-sections text.exists() or entry.exists() or section.exists()
cmp-2 error Composition.section, Composition.section:assessments A section can only have an emptyReason if no entries are included emptyReason.empty() or entry.empty()
dom-2 error Composition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Composition If 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-4 error Composition If 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-5 error Composition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Composition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 17 elements(47 nested mandatory elements)
Must-Support: 18 elements

Slices

This structure defines the following Slices:

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

Maturity: 1

 

Other representations of profile: CSV, Excel, Schematron