<?xml version="1.0" encoding="UTF-8"?>

<ValueSet xmlns="http://hl7.org/fhir">
  <id value="ich-m11-amendment-scope"/>
  <language value="en"/>
  <text>
    <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet ich-m11-amendment-scope</b></p><a name="ich-m11-amendment-scope"> </a><a name="hcich-m11-amendment-scope"> </a><p>This value set expansion contains 3 concepts.</p><table class="codes"><tr><td><b>System</b></td><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a name="ich-m11-amendment-scope-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C68846"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C68846</td><td>Global</td></tr><tr><td><a name="ich-m11-amendment-scope-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217026"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217026</td><td>Not Global</td></tr><tr><td><a name="ich-m11-amendment-scope-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C48660"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C48660</td><td>Not Applicable</td></tr></table></div>
  </text>
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    <valueInteger value="1"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="cds"/>
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  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use"/>
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  <url value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-scope"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.44.48.21"/>
  </identifier>
  <version value="1.0.0-ballot3"/>
  <name value="ICHM11AmendmentScope"/>
  <title value="ICH M11 Amendment Scope Value Set"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-10-02T12:47:35+00:00"/>
  <publisher value="HL7 International / Clinical Decision Support"/>
  <contact>
    <name value="HL7 International / Clinical Decision Support"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/dss"/>
    </telecom>
  </contact>
  <description value="Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217047 drawn from the NCI Thesaurus and represented here in FHIR format. The M11 guidance to 'leave blank' if not applicable has to be replaced by an explicit 'Not Applicable' This content was copied from https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-amendment-scope-vs.html."/>
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    <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.&#xA;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)&#xA;The NCI Thesaurus is released under the CC BY 4.0 license&#xA;Further details at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-amendment-scope-vs.html"/>
  <compose>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
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        <display value="Global"/>
      </concept>
      <concept>
        <code value="C217026"/>
        <display value="Not Global"/>
      </concept>
      <concept>
        <code value="C48660"/>
        <display value="Not Applicable"/>
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    <identifier value="urn:uuid:example-expansion-id"/>
    <timestamp value="2026-10-02T00:00:00Z"/>
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      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C68846"/>
      <display value="Global"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C217026"/>
      <display value="Not Global"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C48660"/>
      <display value="Not Applicable"/>
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