Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## Resource Profile: Research Study Narratives

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 2 | Computable Name: M11ResearchStudyNarratives
Copyright/Legal: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license For more licensing information and links see: licenses.html

Narrative elements associated with a research study following the ICH M11 CeSHarP template. The ICH M11 CeSHarP template for a study protocol specifies the headings to be used to organize protocol content. For a FHIR representation of the protocol to be compliant with this template each of the narrative sections must be organized using these headings. Only if there is material that does not properly belong under one of the M11 headings can additional codes be created.

### Must Support Elements

Attributes type and section.code SHALL be used to specify the structure in accordance with M11 §2

Usages:

- Refer to this Profile: Narrative Elements
- Examples for this Profile: Composition/Exemplar-Narrative-2.1, Composition/Exemplar-Narrative, Composition/JPMA0001-Section5-jpn, Composition/Narrative-Complex... Show 5 more, Composition/Narrative-Composition-Section-per-Section, Composition/Narrative-Composition-per-M11-Section-1, Composition/Narrative-Composition-per-M11-Section-2, Composition/Narrative-Composition-per-M11-Section-3 and Composition/Narrative-Single-Composition

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..* | Composition | 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
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 | S Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. (required)
subject | Σ | 0..* | Reference(Resource) | Reference to the protocol that the narrative refers to
date | Σ | 1..1 | dateTime | Composition editing time
author | Σ | 1..* | Reference(Organization) | Who and/or what authored the composition
title | Σ | 1..1 | string | Human Readable name/title
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 | required | UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. | 📦1.0.0-ballot2 | This IG

#### Constraints

Id | Grade | Path(s) | Description | Expression
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())`

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation
type | S | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. (required)
subject |  | 0..* | Reference(Resource) | Reference to the protocol that the narrative refers to
author |  | 1..* | Reference(Organization) | Who and/or what authored the composition
section |  |  |  |
code |  | 0..1 | CodeableConcept | Identifies the section of the narrative according to M11 codes Binding: UDP Section Codes Value Set (extensible): The value set can only be extended if narrative content falls outside any identified M11 section.
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Composition.type | Base | required | UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. | 📦1.0.0-ballot2 | This IG
Composition.section.​code | Base | extensible | UDP Section Codes Value Set | 📦1.0.0-ballot2 | This IG

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  | 0..* | Composition | 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
extension |  | 0..* | Extension | Additional content defined by implementations
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 | S Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. (required)
category | Σ | 0..* | CodeableConcept | Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject | Σ | 0..* | Reference(Resource) | Reference to the protocol that the narrative refers to
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(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 | personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
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
relatesTo |  | 0..* | BackboneElement | Relationships to other compositions/documents
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
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 |
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.
section | C | 0..* | 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)
code |  | 0..1 | CodeableConcept | Identifies the section of the narrative according to M11 codes Binding: UDP Section Codes Value Set (extensible): The value set can only be extended if narrative content falls outside any identified M11 section.
author |  | 0..* | Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section, when the section is authored by someone other than the 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
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 | required | UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. | 📦1.0.0-ballot2 | This IG
Composition.category | Base | example | Referenced Item Category Value Set | 📍6.0.0-ballot3 | FHIR Std.
Composition.attester.​mode | Base | preferred | Composition Attestation Mode | 📍6.0.0-ballot3 | FHIR Std.
Composition.relatesTo.​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 | UDP Section Codes Value Set | 📦1.0.0-ballot2 | 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.

#### Constraints

Id | Grade | Path(s) | Description | Expression
cmp-1 | error | Composition.section | 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 | 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())`

Summary

Must-Support: 1 element

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  | 0..* | Composition | 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
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 | S Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. (required)
subject | Σ | 0..* | Reference(Resource) | Reference to the protocol that the narrative refers to
date | Σ | 1..1 | dateTime | Composition editing time
author | Σ | 1..* | Reference(Organization) | Who and/or what authored the composition
title | Σ | 1..1 | string | Human Readable name/title
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 | required | UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. | 📦1.0.0-ballot2 | This IG

#### Constraints

Id | Grade | Path(s) | Description | Expression
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())`

Differential View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation
type | S | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. (required)
subject |  | 0..* | Reference(Resource) | Reference to the protocol that the narrative refers to
author |  | 1..* | Reference(Organization) | Who and/or what authored the composition
section |  |  |  |
code |  | 0..1 | CodeableConcept | Identifies the section of the narrative according to M11 codes Binding: UDP Section Codes Value Set (extensible): The value set can only be extended if narrative content falls outside any identified M11 section.
Documentation for this format

#### Terminology Bindings (Differential)

Path | Status | Usage | ValueSet | Version | Source
Composition.type | Base | required | UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. | 📦1.0.0-ballot2 | This IG
Composition.section.​code | Base | extensible | UDP Section Codes Value Set | 📦1.0.0-ballot2 | This IG

Snapshot ViewView

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  | 0..* | Composition | 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
extension |  | 0..* | Extension | Additional content defined by implementations
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 | S Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. (required)
category | Σ | 0..* | CodeableConcept | Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject | Σ | 0..* | Reference(Resource) | Reference to the protocol that the narrative refers to
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(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 | personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
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
relatesTo |  | 0..* | BackboneElement | Relationships to other compositions/documents
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..* | Extension | Additional content defined by implementations
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 |
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.
section | C | 0..* | 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)
code |  | 0..1 | CodeableConcept | Identifies the section of the narrative according to M11 codes Binding: UDP Section Codes Value Set (extensible): The value set can only be extended if narrative content falls outside any identified M11 section.
author |  | 0..* | Reference(Practitioner | PractitionerRole | CareTeam | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section, when the section is authored by someone other than the 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
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 | required | UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set. | 📦1.0.0-ballot2 | This IG
Composition.category | Base | example | Referenced Item Category Value Set | 📍6.0.0-ballot3 | FHIR Std.
Composition.attester.​mode | Base | preferred | Composition Attestation Mode | 📍6.0.0-ballot3 | FHIR Std.
Composition.relatesTo.​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 | UDP Section Codes Value Set | 📦1.0.0-ballot2 | 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.

#### Constraints

Id | Grade | Path(s) | Description | Expression
cmp-1 | error | Composition.section | 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 | 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())`

Summary

Must-Support: 1 element

Maturity: 2

Other representations of profile: CSV, Excel, Schematron