Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## : 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>