Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

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

Extension: Narrative Elements

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-08 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:

You can also check for usages in the FHIR IG Statistics

Formal Views of Extension Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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"

doco 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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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"

doco 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