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

• Narrative Content
• XML
• JSON
• TTL

: JPMA0001 Provided Example - Japanese Language

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<ResearchStudy xmlns="http://hl7.org/fhir">
  <id value="JPMA0001-jpn"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><p class="res-header-id"><b>Generated Narrative: ResearchStudy JPMA0001-jpn</b></p><a name="JPMA0001-jpn"> </a><a name="hcJPMA0001-jpn"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Language: en</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-m11-research-study-profile.html">M11 Research Study Profile</a></p></div><blockquote><p><b>M11 Research Study Extension</b></p><ul><li>originalProtocol: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218485}">Protocol Not Amended</span></li><li>versionDate: 2026-01-14</li></ul></blockquote><p><b>Narrative Elements</b>: <a href="Composition-JPMA0001-Section5-jpn.html">Composition JPMA0001 Protocol Narrative Sections 5.2 and 5.3 (Inclusion/Exclusion Ctriteria)</a></p><p><b>identifier</b>: Sponsor Identifier/JPMA001 (use: usual, )</p><p><b>version</b>: 2.0</p><p><b>title</b>: 経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験</p><h3>Labels</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/title-type short-title}">Short title</span></td><td>2型糖尿病患者への投与</td></tr></table><p><b>status</b>: Active</p><p><b>phase</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C15602}">Phase III Trial</span></p><h3>Recruitments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Eligibility</b></td></tr><tr><td style="display: none">*</td><td><a href="Group-JPMA0001-Criteria-JPN.html">Group Japanese Protocol from Vulcan UDP Eligibility Criteria</a></td></tr></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study">
    <extension url="originalProtocol">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C218485"/>
          <display value="Protocol Not Amended"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="versionDate">
      <valueDate value="2026-01-14"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements">
    <valueReference>🔗 
      <reference value="Composition/JPMA0001-Section5-jpn"/>
    </valueReference>
  </extension>
  <identifier>
    <use value="usual"/>
    <type>
      <text value="Sponsor Identifier"/>
    </type>
    <system value="https://exemplarSponsor.com/sponsor-identifier"/>
    <value value="JPMA001"/>
  </identifier>
  <version value="2.0"/>
  <title
         value="経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として，JPMA001を併用投与した時の安全性および有効性を検討する多施設共同，52週間，ランダム化，並行群間試験"/>
  <label>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/title-type"/>
        <code value="short-title"/>
        <display value="Short title"/>
      </coding>
    </type>
    <value value="2型糖尿病患者への投与"/>
  </label>
  <status value="active"/>
  <phase>
    <coding>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C15602"/>
      <display value="Phase III Trial"/>
    </coding>
  </phase>
  <recruitment>
    <eligibility>🔗 
      <reference value="Group/JPMA0001-Criteria-JPN"/>
    </eligibility>
  </recruitment>
</ResearchStudy>