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

## : ICH M11 Amendment Details Statement Value Set Terminology

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    <ValueSet xmlns="http://hl7.org/fhir">
      <id value="m11-amendment-details-statement-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-amendment-details-statement-vs</b></p><a name="m11-amendment-details-statement-vs"> </a><a name="hcm11-amendment-details-statement-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-C218486">C218486</a></td><td>First Protocol Amendment</td><td>This is the first protocol amendment.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218485">C218485</a></td><td>Protocol Not Amended</td><td>This protocol has not been amended.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218488">C218488</a></td><td>Protocol Previously Amended See Summary of Changes Before the Table of Contents</td><td>This protocol has been amended previously. The Protocol Amendment Summary of Changes for the current amendment is located directly before the Table of Contents. Prior amendment(s) to this protocol are listed in the table below, beginning with the most recent.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218487">C218487</a></td><td>Protocol Previously Amended, Details Presented</td><td>This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).</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-amendment-details-statement-vs"/>
      <version value="1.0.0-ballot2"/>
      <name value="M11AmendmentDetailsStatementVS"/>
      <title value="ICH M11 Amendment Details Statement Value Set Terminology"/>
      <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="Terminology associated with whether or not a protocol has been amended.
    This is ICH M11 Value Set C217274 drawn from the NCI Thesaurus and represented here in FHIR format."/>
      <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="C218486"/>
            <display value="First Protocol Amendment"/>
          </concept>
          <concept>
            <code value="C218485"/>
            <display value="Protocol Not Amended"/>
          </concept>
          <concept>
            <code value="C218488"/>
            <display
                     value="Protocol Previously Amended See Summary of Changes Before the Table of Contents"/>
          </concept>
          <concept>
            <code value="C218487"/>
            <display value="Protocol Previously Amended, Details Presented"/>
          </concept>
        </include>
      </compose>
    </ValueSet>