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

: Limited M11 Section Codes Value Set

Page standards status: Trial-use Maturity Level: 1

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="limited-m11-section-codes"/>
  <language value="en"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet limited-m11-section-codes</b></p><a name="limited-m11-section-codes"> </a><a name="hclimited-m11-section-codes"> </a><p>This value set expansion contains 16 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="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217342"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217342</td><td>ICH M11 Protocol Section 1 PROTOCOL SUMMARY</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217343"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217343</td><td>ICH M11 Protocol Section 2 INTRODUCTION</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217344"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217344</td><td>ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217345"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217345</td><td>ICH M11 Protocol Section 4 TRIAL DESIGN</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217346"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217346</td><td>ICH M11 Protocol Section 5 TRIAL POPULATION</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217347"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217347</td><td>ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217348"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217348</td><td>ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217349"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217349</td><td>ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217350"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217350</td><td>ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217351"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217351</td><td>ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217352"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217352</td><td>ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217353"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217353</td><td>ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217354"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217354</td><td>ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217355"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217355</td><td>ICH M11 Protocol Section 14 APPENDIX: REFERENCES</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217356"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217356</td><td>ICH M11 Protocol Section Title Page</td></tr><tr><td><a name="limited-m11-section-codes-http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl-C217357"> </a><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></td><td style="white-space:nowrap">  C217357</td><td>ICH M11 Protocol Section Amendment Details</td></tr></table></div>
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  <url value="http://hl7.org/fhir/uv/ebm/ValueSet/limited-m11-section-codes"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.44.48.24"/>
  </identifier>
  <version value="1.0.0-ballot3"/>
  <name value="LimitedM11SectionCodes"/>
  <title value="Limited M11 Section Codes 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"/>
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  </contact>
  <description
               value="These codes are specified in the M11 technical specification."/>
  <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."/>
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        <code value="C217342"/>
        <display value="ICH M11 Protocol Section 1 PROTOCOL SUMMARY"/>
      </concept>
      <concept>
        <code value="C217343"/>
        <display value="ICH M11 Protocol Section 2 INTRODUCTION"/>
      </concept>
      <concept>
        <code value="C217344"/>
        <display
                 value="ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"/>
      </concept>
      <concept>
        <code value="C217345"/>
        <display value="ICH M11 Protocol Section 4 TRIAL DESIGN"/>
      </concept>
      <concept>
        <code value="C217346"/>
        <display value="ICH M11 Protocol Section 5 TRIAL POPULATION"/>
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        <display
                 value="ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY"/>
      </concept>
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      </concept>
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        <code value="C217349"/>
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                 value="ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES"/>
      </concept>
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        <display
                 value="ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS"/>
      </concept>
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        <code value="C217351"/>
        <display
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        <code value="C217354"/>
        <display
                 value="ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS"/>
      </concept>
      <concept>
        <code value="C217355"/>
        <display value="ICH M11 Protocol Section 14 APPENDIX: REFERENCES"/>
      </concept>
      <concept>
        <code value="C217356"/>
        <display value="ICH M11 Protocol Section Title Page"/>
      </concept>
      <concept>
        <code value="C217357"/>
        <display value="ICH M11 Protocol Section Amendment Details"/>
      </concept>
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    <timestamp value="2026-10-02T00:00:00Z"/>
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