This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

• Narrative Content
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: M11 Phase Value Set - XML Representation

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="m11-phase-vs"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet m11-phase-vs</b></p><a name="m11-phase-vs"> </a><a name="hcm11-phase-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>C54721</td><td>Early Phase 1</td></tr><tr><td>C15600</td><td>Phase 1</td></tr><tr><td>C15693</td><td>Phase 1/Phase 2</td></tr><tr><td>C198366</td><td>Phase 1/Phase 2/Phase 3</td></tr><tr><td>C198367</td><td>Phase 1/Phase 3</td></tr><tr><td>C217024</td><td>Phase 2/Phase 3/Phase 4</td></tr><tr><td>C15601</td><td>Phase 2</td></tr><tr><td>C15694</td><td>Phase 2/Phase 3</td></tr><tr><td>C217025</td><td>Phase 3/Phase 4</td></tr><tr><td>C15602</td><td>Phase 3</td></tr><tr><td>C15603</td><td>Phase 4</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-phase-vs"/>
  <version value="1.0.0-ballot"/>
  <name value="M11PhaseVS"/>
  <title value="M11 Phase Value Set"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2025-08-01T12:18:30+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 value set $NCIT#C217045 ICH M11 Trial Phase Value Set Terminology
These codes represent phases of a study as defined by ICH."/>
  <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="C54721"/>
        <display value="Early Phase 1"/>
      </concept>
      <concept>
        <code value="C15600"/>
        <display value="Phase 1"/>
      </concept>
      <concept>
        <code value="C15693"/>
        <display value="Phase 1/Phase 2"/>
      </concept>
      <concept>
        <code value="C198366"/>
        <display value="Phase 1/Phase 2/Phase 3"/>
      </concept>
      <concept>
        <code value="C198367"/>
        <display value="Phase 1/Phase 3"/>
      </concept>
      <concept>
        <code value="C217024"/>
        <display value="Phase 2/Phase 3/Phase 4"/>
      </concept>
      <concept>
        <code value="C15601"/>
        <display value="Phase 2"/>
      </concept>
      <concept>
        <code value="C15694"/>
        <display value="Phase 2/Phase 3"/>
      </concept>
      <concept>
        <code value="C217025"/>
        <display value="Phase 3/Phase 4"/>
      </concept>
      <concept>
        <code value="C15602"/>
        <display value="Phase 3"/>
      </concept>
      <concept>
        <code value="C15603"/>
        <display value="Phase 4"/>
      </concept>
    </include>
  </compose>
</ValueSet>