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

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: ICH M11 Amendment Scope Value Set Terminology

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="m11-study-amendment-scope-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 m11-study-amendment-scope-vs</b></p><a name="m11-study-amendment-scope-vs"> </a><a name="hcm11-study-amendment-scope-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-C68846">C68846</a></td><td>Global</td><td>Covering or affecting the whole of a system.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C217026">C217026</a></td><td>Not Global</td><td>Covering or affecting only a portion of the entire system.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C48660">C48660</a></td><td>Not Applicable</td><td>Determination of a value is not relevant in the current context.</td></tr></table></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="0"/>
  </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/m11-study-amendment-scope-vs"/>
  <version value="1.0.0-ballot2"/>
  <name value="M11AmendmentScopeVS"/>
  <title value="ICH M11 Amendment Scope Value Set Terminology"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-04-02T08:57:07+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="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 &quot;leave blank&quot; if not applicable has to be replaced by an explicit &quot;Not Applicable&quot;"/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
        <code value="C68846"/>
        <display value="Global"/>
      </concept>
      <concept>
        <code value="C217026"/>
        <display value="Not Global"/>
      </concept>
      <concept>
        <code value="C48660"/>
        <display value="Not Applicable"/>
      </concept>
    </include>
  </compose>
</ValueSet>