Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: ICH M11 Reason for Amendment Value Set

Page standards status: Trial-use Maturity Level: 1

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="ich-m11-amendment-reason"/>
  <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-reason</b></p><a name="ich-m11-amendment-reason"> </a><a name="hcich-m11-amendment-reason"> </a><p>This value set expansion contains 15 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-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218497"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218497</td><td>Change in Standard Of Care Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218496"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218496</td><td>Change in Strategy Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218495"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218495</td><td>IMP Addition Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218501"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218501</td><td>Inconsistency and/or Error in the Protocol Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218499"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218499</td><td>Investigator/Site Feedback Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218492"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218492</td><td>IRB/IEC Feedback Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218494"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218494</td><td>Manufacturing Change Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218498"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218498</td><td>New Data Available (Other Than Safety Data) Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218491"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218491</td><td>New Regulatory Guidance Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218493"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218493</td><td>New Safety Information Available Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-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><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C17649"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C17649</td><td>Other</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218502"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218502</td><td>Protocol Design Error Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218500"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218500</td><td>Recruitment Difficulty Amendment Reason</td></tr><tr><td><a name="ich-m11-amendment-reason-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C218490"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C218490</td><td>Regulatory Agency Request to Amend Amendment Reason</td></tr></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="cds"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use"/>
  </extension>
  <url value="http://hl7.org/fhir/uv/ebm/ValueSet/ich-m11-amendment-reason"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.44.48.19"/>
  </identifier>
  <version value="1.0.0-ballot3"/>
  <name value="ICHM11AmendmentReason"/>
  <title value="ICH M11 Reason for Amendment 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 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. This content was copied from https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-study-amendment-reason-vs.html."/>
  <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
Further details at https://hl7.org/fhir/uv/clinical-study-protocol/2026May/en/ValueSet-m11-amendment-reason-vs.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>
  <expansion>
    <identifier value="urn:uuid:example-expansion-id"/>
    <timestamp value="2026-10-02T00:00:00Z"/>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218497"/>
      <display value="Change in Standard Of Care Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218496"/>
      <display value="Change in Strategy Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218495"/>
      <display value="IMP Addition Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218501"/>
      <display
               value="Inconsistency and/or Error in the Protocol Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218499"/>
      <display value="Investigator/Site Feedback Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218492"/>
      <display value="IRB/IEC Feedback Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218494"/>
      <display value="Manufacturing Change Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218498"/>
      <display
               value="New Data Available (Other Than Safety Data) Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218491"/>
      <display value="New Regulatory Guidance Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218493"/>
      <display value="New Safety Information Available Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C48660"/>
      <display value="Not Applicable"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C17649"/>
      <display value="Other"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218502"/>
      <display value="Protocol Design Error Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218500"/>
      <display value="Recruitment Difficulty Amendment Reason"/>
    </contains>
    <contains>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C218490"/>
      <display value="Regulatory Agency Request to Amend Amendment Reason"/>
    </contains>
  </expansion>
</ValueSet>