Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-narratives | Version: 1.0.0-ballot2 | ||||
| Standards status: Trial-use Active as of 2026-04-02 | Maturity Level: 2 | Computable Name: M11ResearchStudyNarratives | |||
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.
Attributes type and section.code SHALL be used to specify the structure in accordance with M11 §2
Usages:
You can also check for usages in the FHIR IG Statistics
Description Differentials, Snapshots, and other representations.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  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 |
SΣ | 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 | ||||
| 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 |
| 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: |
|---|---|---|---|---|
| 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 | ||||
| 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: | ||||
|---|---|---|---|---|---|---|---|---|
| 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
| |||||
| 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 |
SΣ | 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 | ||||||||
| 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. |
| 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())
|
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| 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 |
SΣ | 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 | ||||
| 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 |
| 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: |
|---|---|---|---|---|
| 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 | ||||
| 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: | ||||
|---|---|---|---|---|---|---|---|---|
| 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
| |||||
| 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 |
SΣ | 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 | ||||||||
| 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. |
| 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())
|
Other representations of profile: CSV, Excel, Schematron
IG © 2026+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.clinical-study-protocol#1.0.0-ballot2 based on FHIR 6.0.0-ballot3.
Generated
2026-04-02
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