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

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: M11ReportSection10

Profile of Composition for Evidence Based Medicine IG. The M11ReportSection10 Profile is used for section 10 (Statistical Considerations) 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:

• Refer to this Profile: M11ReportContainer
• Examples for this Profile: Composition/568052 and Composition/568067

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
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:statistics	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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL 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: section10-statistics
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:statistics	SC	1..1	BackboneElement	Composition is broken into sections Constraints: cmp-1, cmp-2
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:considerations	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisSets	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisBaseline	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses of Demographics and Other Baseline Variables
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Primary Objective(s)
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisPrimaryInstance	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:statisticalModel	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Primary Estimand(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Secondary Objective(s)
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisSecondaryInstance	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:statisticalModel	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:exploratoryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Exploratory Objective(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:multiplicity	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Multiplicity Adjustments
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sampleSize	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
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:statistics	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:statistics	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:statistics	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()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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:statistics		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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
text		1..1	string	Plain text representation of the concept Required Pattern: section10-statistics
Slices for section		1..1	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text
section:statistics	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
code
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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
text		1..1	string	Plain text representation of the concept Required Pattern: section10-statistics
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		6..*		Nested Section Slice: Unordered, Open by value:code.text
section:considerations	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations
code
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: C218626
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.1 General Considerations
text		1..1	string	Plain text representation of the concept Required Pattern: section10.1-general-considerations
text		1..1	Narrative	Text summary of the section, for human interpretation
section:analysisSets	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
code
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: C218627
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.2 Analysis Sets
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2-analysis-sets
text		1..1	Narrative	Text summary of the section, for human interpretation
section:analysisBaseline	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses of Demographics and Other Baseline Variables
code
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: C218628
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3-analyses-demographics
text		1..1	Narrative	Text summary of the section, for human interpretation
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Primary Objective(s)
code
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: C218629
display		1..1	string	Representation defined by the system Fixed Value: section10.4-analysis-primary-objective
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4-analysis-primary-objective
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		1..*		Nested Section Slice: Unordered, Open by value:code.text
section:analysisPrimaryInstance	S	1..*	BackboneElement	Nested Section
code
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: C218630
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1 Primary Objective
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1-analysis-primary-objective-instance
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
code
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: C218631
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.1-statistical-method
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Primary Estimand(s)
code
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: C218632
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.2-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
code
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: C218633
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
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: C218634
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
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: C218635
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Secondary Objective(s)
code
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: C218636
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5-analysis-secondary-objective
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		1..*		Nested Section Slice: Unordered, Open by value:code.text
section:analysisSecondaryInstance	S	1..*	BackboneElement	Nested Section
code
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: C218637
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1 Secondary Objective
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1-analysis-secondary-objective-instance
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
code
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: C218638
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.1-statistical-method
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
code
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: C218639
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.2-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
code
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: C218640
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
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: C218641
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
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: C218642
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:exploratoryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Exploratory Objective(s)
code
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: C218643
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.6-analysis-exploratory-objective
text		1..1	Narrative	Text summary of the section, for human interpretation
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
code
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: C218644
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.7 Safety Analyses
text		1..1	string	Plain text representation of the concept Required Pattern: section10.7-safety-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
code
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: C218645
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.8 Other Analyses
text		1..1	string	Plain text representation of the concept Required Pattern: section10.8-other-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:multiplicity	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Multiplicity Adjustments
code
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: C218647
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.10 Multiplicity Adjustments
text		1..1	string	Plain text representation of the concept Required Pattern: section10.10-multiplicity-adjustments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
code
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: C218646
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.9 Interim Analyses
text		1..1	string	Plain text representation of the concept Required Pattern: section10.9-interim-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sampleSize	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
code
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: C218648
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.11 Sample Size Determination
text		1..1	string	Plain text representation of the concept Required Pattern: section10.11-sample-size-determination
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Bindings Purpose 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:statistics	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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL 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: section10-statistics
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:statistics	SC	1..1	BackboneElement	Composition is broken into sections Constraints: cmp-1, cmp-2
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL 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: section10-statistics
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:considerations	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218626
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.1 General 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: section10.1-general-considerations
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisSets	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218627
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.2 Analysis Sets
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: section10.2-analysis-sets
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisBaseline	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses of Demographics and Other Baseline Variables
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218628
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables
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: section10.3-analyses-demographics
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Primary Objective(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218629
display		1..1	string	Representation defined by the system Fixed Value: section10.4-analysis-primary-objective
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: section10.4-analysis-primary-objective
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisPrimaryInstance	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218630
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1 Primary Objective
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: section10.4.1-analysis-primary-objective-instance
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:statisticalModel	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218631
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method
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: section10.4.1.1-statistical-method
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Primary Estimand(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218632
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)
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: section10.4.1.2-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218633
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)
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: section10.4.1.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218634
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis
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: section10.4.1.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218635
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis
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: section10.4.1.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Secondary Objective(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218636
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)
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: section10.5-analysis-secondary-objective
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisSecondaryInstance	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218637
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1 Secondary Objective
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: section10.5.1-analysis-secondary-objective-instance
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:statisticalModel	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218638
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method
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: section10.5.1.1-statistical-method
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218639
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)
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: section10.5.1.2-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218640
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)
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: section10.5.1.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218641
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis
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: section10.5.1.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218642
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis
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: section10.5.1.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:exploratoryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Exploratory Objective(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218643
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)
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: section10.6-analysis-exploratory-objective
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218644
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.7 Safety Analyses
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: section10.7-safety-analyses
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218645
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.8 Other Analyses
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: section10.8-other-analyses
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:multiplicity	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Multiplicity Adjustments
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218647
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.10 Multiplicity Adjustments
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: section10.10-multiplicity-adjustments
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218646
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.9 Interim Analyses
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: section10.9-interim-analyses
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sampleSize	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218648
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.11 Sample Size Determination
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: section10.11-sample-size-determination
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
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:statistics	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:statistics.​code	Base	extensible	EvidenceReportSectionCode Value Set	📦1.0.0-ballot3	This IG
Composition.section:statistics.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section.code	Base	extensible	EvidenceReportSectionCode Value Set	📦1.0.0-ballot3	This IG
Composition.section:statistics.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:considerations.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:considerations.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:considerations.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisSets.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisSets.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisSets.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisBaseline.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisBaseline.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisBaseline.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:statisticalModel.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:statisticalModel.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:statisticalModel.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:intercurrentEventHandling.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:intercurrentEventHandling.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:intercurrentEventHandling.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:missingData.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:missingData.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:missingData.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:sensitvityAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:sensitvityAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:sensitvityAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:supplementaryAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:supplementaryAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:supplementaryAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:statisticalModel.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:statisticalModel.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:statisticalModel.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:intercurrentEventHandling.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:intercurrentEventHandling.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:intercurrentEventHandling.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:missingData.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:missingData.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:missingData.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:sensitvityAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:sensitvityAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:sensitvityAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:supplementaryAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:supplementaryAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:supplementaryAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:exploratoryAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:exploratoryAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:exploratoryAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:safetyAnalyses.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:safetyAnalyses.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:safetyAnalyses.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:otherAnalyses.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:otherAnalyses.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:otherAnalyses.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:multiplicity.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:multiplicity.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:multiplicity.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:interimAnalyses.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:interimAnalyses.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:interimAnalyses.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:sampleSize.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:sampleSize.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:sampleSize.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:statistics	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:statistics	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: 22 elements(63 nested mandatory elements)
Must-Support: 24 elements

Structures

This structure refers to these other structures:

• VariableDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition)
• EndpointAnalysisPlan (http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan)

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

Maturity: 1

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
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:statistics	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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL 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: section10-statistics
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:statistics	SC	1..1	BackboneElement	Composition is broken into sections Constraints: cmp-1, cmp-2
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:considerations	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisSets	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisBaseline	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses of Demographics and Other Baseline Variables
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Primary Objective(s)
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisPrimaryInstance	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:statisticalModel	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Primary Estimand(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Secondary Objective(s)
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:analysisSecondaryInstance	S	1..*	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:statisticalModel	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:missingData	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:exploratoryAnalysis	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Exploratory Objective(s)
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:multiplicity	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Multiplicity Adjustments
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:sampleSize	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
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:statistics	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:statistics	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:statistics	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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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:statistics		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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
text		1..1	string	Plain text representation of the concept Required Pattern: section10-statistics
Slices for section		1..1	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text
section:statistics	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
code
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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
text		1..1	string	Plain text representation of the concept Required Pattern: section10-statistics
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		6..*		Nested Section Slice: Unordered, Open by value:code.text
section:considerations	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations
code
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: C218626
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.1 General Considerations
text		1..1	string	Plain text representation of the concept Required Pattern: section10.1-general-considerations
text		1..1	Narrative	Text summary of the section, for human interpretation
section:analysisSets	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
code
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: C218627
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.2 Analysis Sets
text		1..1	string	Plain text representation of the concept Required Pattern: section10.2-analysis-sets
text		1..1	Narrative	Text summary of the section, for human interpretation
section:analysisBaseline	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses of Demographics and Other Baseline Variables
code
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: C218628
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables
text		1..1	string	Plain text representation of the concept Required Pattern: section10.3-analyses-demographics
text		1..1	Narrative	Text summary of the section, for human interpretation
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Primary Objective(s)
code
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: C218629
display		1..1	string	Representation defined by the system Fixed Value: section10.4-analysis-primary-objective
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4-analysis-primary-objective
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		1..*		Nested Section Slice: Unordered, Open by value:code.text
section:analysisPrimaryInstance	S	1..*	BackboneElement	Nested Section
code
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: C218630
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1 Primary Objective
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1-analysis-primary-objective-instance
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		3..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
code
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: C218631
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.1-statistical-method
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Primary Estimand(s)
code
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: C218632
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.2-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
code
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: C218633
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
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: C218634
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
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: C218635
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis
text		1..1	string	Plain text representation of the concept Required Pattern: section10.4.1.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Secondary Objective(s)
code
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: C218636
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5-analysis-secondary-objective
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		1..*		Nested Section Slice: Unordered, Open by value:code.text
section:analysisSecondaryInstance	S	1..*	BackboneElement	Nested Section
code
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: C218637
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1 Secondary Objective
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1-analysis-secondary-objective-instance
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
section:statisticalModel	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
code
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: C218638
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.1-statistical-method
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
code
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: C218639
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.2-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:missingData	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
code
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: C218640
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.3-missing-data-handling
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code
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: C218641
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.4-sensitivity-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code
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: C218642
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis
text		1..1	string	Plain text representation of the concept Required Pattern: section10.5.1.5-supplementary-analysis
text		1..1	Narrative	Text summary of the section, for human interpretation
section:exploratoryAnalysis	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Exploratory Objective(s)
code
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: C218643
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)
text		1..1	string	Plain text representation of the concept Required Pattern: section10.6-analysis-exploratory-objective
text		1..1	Narrative	Text summary of the section, for human interpretation
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
code
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: C218644
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.7 Safety Analyses
text		1..1	string	Plain text representation of the concept Required Pattern: section10.7-safety-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
code
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: C218645
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.8 Other Analyses
text		1..1	string	Plain text representation of the concept Required Pattern: section10.8-other-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:multiplicity	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Multiplicity Adjustments
code
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: C218647
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.10 Multiplicity Adjustments
text		1..1	string	Plain text representation of the concept Required Pattern: section10.10-multiplicity-adjustments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
code
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: C218646
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.9 Interim Analyses
text		1..1	string	Plain text representation of the concept Required Pattern: section10.9-interim-analyses
text		1..1	Narrative	Text summary of the section, for human interpretation
section:sampleSize	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
code
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: C218648
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.11 Sample Size Determination
text		1..1	string	Plain text representation of the concept Required Pattern: section10.11-sample-size-determination
text		1..1	Narrative	Text summary of the section, for human interpretation
entry		0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
Documentation for this format

Snapshot ViewView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Bindings Purpose 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:statistics	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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL 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: section10-statistics
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:statistics	SC	1..1	BackboneElement	Composition is broken into sections Constraints: cmp-1, cmp-2
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Considerations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218625
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10 STATISTICAL 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: section10-statistics
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		6..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: EvidenceReportSectionCode Value Set (extensible)
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:considerations	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: General Considerations
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218626
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.1 General 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: section10.1-general-considerations
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisSets	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analysis Sets
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218627
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.2 Analysis Sets
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: section10.2-analysis-sets
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisBaseline	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses of Demographics and Other Baseline Variables
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218628
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables
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: section10.3-analyses-demographics
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisPrimaryObjective	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Primary Objective(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218629
display		1..1	string	Representation defined by the system Fixed Value: section10.4-analysis-primary-objective
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: section10.4-analysis-primary-objective
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisPrimaryInstance	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218630
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1 Primary Objective
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: section10.4.1-analysis-primary-objective-instance
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		3..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:statisticalModel	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218631
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method
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: section10.4.1.1-statistical-method
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Primary Estimand(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218632
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)
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: section10.4.1.2-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Primary Estimand(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218633
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)
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: section10.4.1.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218634
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis
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: section10.4.1.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218635
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis
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: section10.4.1.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:secondaryAnalysis	S	0..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Secondary Objective(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218636
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)
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: section10.5-analysis-secondary-objective
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		1..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:analysisSecondaryInstance	S	1..*	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218637
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1 Secondary Objective
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: section10.5.1-analysis-secondary-objective-instance
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(VariableDefinition)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:statisticalModel	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Statistical Analysis Method
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218638
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method
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: section10.5.1.1-statistical-method
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:intercurrentEventHandling	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Data in Relation to Secondary Estimand(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218639
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)
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: section10.5.1.2-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:missingData	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Handling of Missing Data in Relation to Secondary Estimand(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218640
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)
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: section10.5.1.3-missing-data-handling
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sensitvityAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sensitivity Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218641
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis
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: section10.5.1.4-sensitivity-analysis
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:supplementaryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Supplementary Analysis
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218642
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis
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: section10.5.1.5-supplementary-analysis
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:exploratoryAnalysis	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Analyses Associated with the Exploratory Objective(s)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218643
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)
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: section10.6-analysis-exploratory-objective
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:safetyAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Safety Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218644
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.7 Safety Analyses
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: section10.7-safety-analyses
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:otherAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Other Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218645
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.8 Other Analyses
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: section10.8-other-analyses
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:multiplicity	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Multiplicity Adjustments
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218647
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.10 Multiplicity Adjustments
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: section10.10-multiplicity-adjustments
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:interimAnalyses	S	0..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Interim Analyses
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218646
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.9 Interim Analyses
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: section10.9-interim-analyses
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
section:sampleSize	S	1..1	BackboneElement	Nested Section
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: Sample Size Determination
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding		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: C218648
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 10.11 Sample Size Determination
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: section10.11-sample-size-determination
author		0..*	Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section, when the section is authored by someone other than the composition.author
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	C	0..*	Reference(EndpointAnalysisPlan)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
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:statistics	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:statistics.​code	Base	extensible	EvidenceReportSectionCode Value Set	📦1.0.0-ballot3	This IG
Composition.section:statistics.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section.code	Base	extensible	EvidenceReportSectionCode Value Set	📦1.0.0-ballot3	This IG
Composition.section:statistics.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:considerations.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:considerations.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:considerations.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisSets.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisSets.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisSets.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisBaseline.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisBaseline.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisBaseline.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:statisticalModel.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:statisticalModel.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:statisticalModel.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:intercurrentEventHandling.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:intercurrentEventHandling.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:intercurrentEventHandling.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:missingData.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:missingData.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:missingData.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:sensitvityAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:sensitvityAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:sensitvityAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:supplementaryAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:supplementaryAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:analysisPrimaryObjective.​section:analysisPrimaryInstance.​section:supplementaryAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:statisticalModel.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:statisticalModel.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:statisticalModel.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:intercurrentEventHandling.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:intercurrentEventHandling.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:intercurrentEventHandling.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:missingData.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:missingData.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:missingData.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:sensitvityAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:sensitvityAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:sensitvityAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:supplementaryAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:supplementaryAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:secondaryAnalysis.​section:analysisSecondaryInstance.​section:supplementaryAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:exploratoryAnalysis.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:exploratoryAnalysis.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:exploratoryAnalysis.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:safetyAnalyses.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:safetyAnalyses.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:safetyAnalyses.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:otherAnalyses.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:otherAnalyses.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:otherAnalyses.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:multiplicity.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:multiplicity.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:multiplicity.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:interimAnalyses.​code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:interimAnalyses.​orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:interimAnalyses.​emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:sampleSize.code	Base	example	Document Section Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:sampleSize.orderedBy	Base	preferred	List Order Codes	📍6.0.0-ballot3	FHIR Std.
Composition.section:statistics.​section:sampleSize.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:statistics	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:statistics	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: 22 elements(63 nested mandatory elements)
Must-Support: 24 elements

Structures

This structure refers to these other structures:

• VariableDefinition (http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition)
• EndpointAnalysisPlan (http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan)

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

Maturity: 1