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

## : UDP Related Artifact Type Value Set

Page standards status: Trial-use | Maturity Level: 1

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    <ValueSet xmlns="http://hl7.org/fhir">
      <id value="udp-related-artifact-type-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-related-artifact-type-vs</b></p><a name="udp-related-artifact-type-vs"> </a><a name="hcudp-related-artifact-type-vs"> </a><p>This value set includes codes based on the following rules:</p><ul><li>Import all the codes that are contained in <a href="http://terminology.hl7.org/7.1.0/ValueSet-artifact-relationship-type.html">Artifact Relationship Type</a></li><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-C218694">C218694</a></td><td>Protocol Amendment Details</td><td>Particulars about the protocol amendment, considered individually and in relation to a whole.</td></tr></table></li></ul></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
        <valueInteger value="1"/>
      </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-related-artifact-type-vs"/>
      <version value="1.0.0-ballot2"/>
      <name value="UDPRelatedArtifactType"/>
      <title value="UDP Related Artifact Type Value Set"/>
      <status value="active"/>
      <experimental value="false"/>
      <date value="2026-04-09T17:15:23+10:00"/>
      <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="These codes represent the relationship between an artifact and it related target.
    There is an HL7 value set for Related Artifact type - this has &quot;extensible&quot; binding.  This will
    be included in this value set.
    This is a UDP specific value set using NCIT codes to extend a required HL7 value set.

    The HL7 value set does not have the concept of information that is a summary of an amendment that has been applied.
    The amends and amended-with concepts talk of content that must be applied to get the final version.  M11 only
    wants to know what has been done - it is more of an amendment trail than an actual amendment.  M11 uses a concept
    from the NCI Thesaurus which is suitable for use here."/>
      <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>
          <valueSet
                    value="http://terminology.hl7.org/ValueSet/artifact-relationship-type"/>
        </include>
        <include>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <concept>
            <code value="C218694"/>
            <display value="Protocol Amendment Details"/>
          </concept>
        </include>
      </compose>
    </ValueSet>