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

## Extension: Narrative Elements

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 2 | Computable Name: NarrativeElements
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 content for the ResearchStudy.

Context of Use

This extension may be used on the following element(s)

- Element ID: `http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy`

Usage info

Usages:

- Use this Extension: M11 Research Study Profile
- Examples for this Extension: ResearchStudy/Exemplar-ResearchStudy-001, ResearchStudy/JPMA0001-jpn, ResearchStudy/ResearchStudy-Composition-Section-Per-Section-001, ResearchStudy/ResearchStudy-Narrative-Comp-Per-M11-001... Show 2 more, ResearchStudy/ResearchStudy-Narrative-Complex-001 and ResearchStudy/ResearchStudy-Single-Composition-001

You can also check for usages in the FHIR IG Statistics

### Formal Views of Extension Content

Description Differentials, Snapshots, and other representations.

- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Narrative Elements
extension |  | 0..0 |  | Extension
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"
value[x] |  | 0..1 | Reference(Research Study Narratives) | Pointer to the narrative content for the protocol
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Narrative Elements
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..0 |  | Extension Slice: Unordered, Open by value:url
url | Σ | 1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"
value[x] | Σ | 0..1 | Reference(Research Study Narratives) | Pointer to the narrative content for the protocol
Documentation for this format

#### Constraints

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

Simple Extension with the type Reference: Narrative content for the ResearchStudy.

Maturity: 2

Differential ViewDifferential View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Narrative Elements
extension |  | 0..0 |  | Extension
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"
value[x] |  | 0..1 | Reference(Research Study Narratives) | Pointer to the narrative content for the protocol
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Narrative Elements
id |  | 0..1 | id | Unique id for inter-element referencing
extension |  | 0..0 |  | Extension Slice: Unordered, Open by value:url
url | Σ | 1..1 | uri | "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"
value[x] | Σ | 0..1 | Reference(Research Study Narratives) | Pointer to the narrative content for the protocol
Documentation for this format

#### Constraints

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

Simple Extension with the type Reference: Narrative content for the ResearchStudy.

Maturity: 2

Other representations of profile: CSV, Excel, Schematron