Pharmaceutical Research Protocol (Vulcan UDP), 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-ballot 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

• Narrative Content
• XML
• JSON
• TTL

: Study Amendment Reason Value Set - XML Representation

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="m11-study-amendment-reason-vs"/>
  <text>
    <status value="generated"/>
    <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="http://terminology.hl7.org/6.5.0/CodeSystem-v3-nciThesaurus.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C218490</td><td>Regulatory Agency Request To Amend</td></tr><tr><td>C218491</td><td>New Regulatory Guidance</td></tr><tr><td>C218492</td><td>IRB/IEC Feedback</td></tr><tr><td>C218493</td><td>New Safety Information Available</td></tr><tr><td>C218494</td><td>Manufacturing Change</td></tr><tr><td>C218495</td><td>IMP Addition</td></tr><tr><td>C218496</td><td>Change In Strategy</td></tr><tr><td>C218497</td><td>Change In Standard Of Care</td></tr><tr><td>C218498</td><td>New Data Available (Other Than Safety Data)</td></tr><tr><td>C218499</td><td>Investigator/Site Feedback</td></tr><tr><td>C218500</td><td>Recruitment Difficulty</td></tr><tr><td>C218501</td><td>Inconsistency And/Or Error In The Protocol</td></tr><tr><td>C218502</td><td>Protocol Design Error</td></tr><tr><td>C17649</td><td>Other</td></tr><tr><td>C48660</td><td>Not Applicable</td></tr></table></li></ul></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="2"/>
  </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/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs"/>
  <version value="1.0.0-ballot"/>
  <name value="M11StudyAmendmentReasonVS"/>
  <title value="Study Amendment Reason Value Set"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2025-07-31T20:39:04+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="Codes drawn from NCI Thesaurus to represent the reasons a study was amended."/>
  <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="C218490"/>
        <display value="Regulatory Agency Request To Amend"/>
      </concept>
      <concept>
        <code value="C218491"/>
        <display value="New Regulatory Guidance"/>
      </concept>
      <concept>
        <code value="C218492"/>
        <display value="IRB/IEC Feedback"/>
      </concept>
      <concept>
        <code value="C218493"/>
        <display value="New Safety Information Available"/>
      </concept>
      <concept>
        <code value="C218494"/>
        <display value="Manufacturing Change"/>
      </concept>
      <concept>
        <code value="C218495"/>
        <display value="IMP Addition"/>
      </concept>
      <concept>
        <code value="C218496"/>
        <display value="Change In Strategy"/>
      </concept>
      <concept>
        <code value="C218497"/>
        <display value="Change In Standard Of Care"/>
      </concept>
      <concept>
        <code value="C218498"/>
        <display value="New Data Available (Other Than Safety Data)"/>
      </concept>
      <concept>
        <code value="C218499"/>
        <display value="Investigator/Site Feedback"/>
      </concept>
      <concept>
        <code value="C218500"/>
        <display value="Recruitment Difficulty"/>
      </concept>
      <concept>
        <code value="C218501"/>
        <display value="Inconsistency And/Or Error In The Protocol"/>
      </concept>
      <concept>
        <code value="C218502"/>
        <display value="Protocol Design Error"/>
      </concept>
      <concept>
        <code value="C17649"/>
        <display value="Other"/>
      </concept>
      <concept>
        <code value="C48660"/>
        <display value="Not Applicable"/>
      </concept>
    </include>
  </compose>
</ValueSet>