Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

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## : ICH M11 Reason for Amendment Value Set Terminology

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    <ValueSet xmlns="http://hl7.org/fhir">
      <id value="m11-study-amendment-reason-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-reason-vs</b></p><a name="m11-study-amendment-reason-vs"> </a><a name="hcm11-study-amendment-reason-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-C218497">C218497</a></td><td>Change in Standard Of Care Amendment Reason</td><td>A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218496">C218496</a></td><td>Change in Strategy Amendment Reason</td><td>A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218495">C218495</a></td><td>IMP Addition Amendment Reason</td><td>The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218501">C218501</a></td><td>Inconsistency and/or Error in the Protocol Amendment Reason</td><td>An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218499">C218499</a></td><td>Investigator/Site Feedback Amendment Reason</td><td>Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218492">C218492</a></td><td>IRB/IEC Feedback Amendment Reason</td><td>Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218494">C218494</a></td><td>Manufacturing Change Amendment Reason</td><td>A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218498">C218498</a></td><td>New Data Available (Other Than Safety Data) Amendment Reason</td><td>Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218491">C218491</a></td><td>New Regulatory Guidance Amendment Reason</td><td>A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218493">C218493</a></td><td>New Safety Information Available Amendment Reason</td><td>Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.</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><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C17649">C17649</a></td><td>Other</td><td>Different than the one(s) previously specified or mentioned.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218502">C218502</a></td><td>Protocol Design Error Amendment Reason</td><td>A protocol design error necessitates a change(s) to, or formal clarification of, a document.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218500">C218500</a></td><td>Recruitment Difficulty Amendment Reason</td><td>Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218490">C218490</a></td><td>Regulatory Agency Request to Amend Amendment Reason</td><td>A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol.</td></tr></table></li></ul></div>
      </text>
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                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
        <valueInteger value="0"/>
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      <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-reason-vs"/>
      <version value="1.0.0-ballot2"/>
      <name value="M11StudyAmendmentReasonVS"/>
      <title value="ICH M11 Reason for Amendment 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 the reason for amendment value set codelist of the ICH M11 protocol template.
    This is ICH M11 Value Set C217276 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="C218497"/>
            <display value="Change in Standard Of Care Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218496"/>
            <display value="Change in Strategy Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218495"/>
            <display value="IMP Addition Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218501"/>
            <display
                     value="Inconsistency and/or Error in the Protocol Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218499"/>
            <display value="Investigator/Site Feedback Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218492"/>
            <display value="IRB/IEC Feedback Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218494"/>
            <display value="Manufacturing Change Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218498"/>
            <display
                     value="New Data Available (Other Than Safety Data) Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218491"/>
            <display value="New Regulatory Guidance Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218493"/>
            <display value="New Safety Information Available Amendment Reason"/>
          </concept>
          <concept>
            <code value="C48660"/>
            <display value="Not Applicable"/>
          </concept>
          <concept>
            <code value="C17649"/>
            <display value="Other"/>
          </concept>
          <concept>
            <code value="C218502"/>
            <display value="Protocol Design Error Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218500"/>
            <display value="Recruitment Difficulty Amendment Reason"/>
          </concept>
          <concept>
            <code value="C218490"/>
            <display value="Regulatory Agency Request to Amend Amendment Reason"/>
          </concept>
        </include>
      </compose>
    </ValueSet>