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

: UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set.

Page standards status: Trial-use Maturity Level: 2

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="udp-narrative-elements-vs"/>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet udp-narrative-elements-vs</b></p><a name="udp-narrative-elements-vs"> </a><a name="hcudp-narrative-elements-vs"> </a><ul><li>Include these codes as defined in <a href="CodeSystem-ncit-cs.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><span title="Version is not explicitly stated, which means it is fixed to the version provided in this specification"> version &#x1F4E6;1.0.0-ballot2</span><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C207508">C207508</a></td><td>Narrative Content Text</td><td>A textual representation of the narrative content.</td></tr></table></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="2"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-narrative-elements-vs"/>
  <version value="1.0.0-ballot2"/>
  <name value="UDPNarrativeElementsVS"/>
  <title
         value="UDP Narrative Elements Value Set using NCIT codes to create a FHIR value set."/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-04-08T21:09:32+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="UDP@HL7Vulcan.org"/>
    </telecom>
  </contact>
  <description
               value="Composition Types to Manage Protocol Narrative Elements. This is a UDP specific value set."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <copyright
             value="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

For more licensing information and links see: [licenses.html](licenses.html)"/>
  <compose>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
        <code value="C207508"/>
        <display value="Narrative Content Text"/>
      </concept>
    </include>
  </compose>
</ValueSet>