Clinical Study Protocol
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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

: ICH M11 Reason for Amendment Value Set Terminology

Page standards status: Trial-use Maturity Level: 0

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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">
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             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
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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="2026-04-02T08:57:07+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 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>
  <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>