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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{
  "resourceType" : "ResearchStudy",
  "id" : "JPMA0001-jpn",
  "meta" : {
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"
    ]
  },
  "language" : "en",
  "text" : {
    "status" : "extensions",
    "div" : "<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\u00a0(use:\u00a0usual,\u00a0)</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>"
  },
  "extension" : [
    {
      "extension" : [
        {
          "url" : "originalProtocol",
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218485",
                "display" : "Protocol Not Amended"
              }
            ]
          }
        },
        {
          "url" : "versionDate",
          "valueDate" : "2026-01-14"
        }
      ],
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"
    },
    {
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements",
      "valueReference" : {
        🔗 "reference" : "Composition/JPMA0001-Section5-jpn"
      }
    }
  ],
  "identifier" : [
    {
      "use" : "usual",
      "type" : {
        "text" : "Sponsor Identifier"
      },
      "system" : "https://exemplarSponsor.com/sponsor-identifier",
      "value" : "JPMA001"
    }
  ],
  "version" : "2.0",
  "title" : "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" : "http://hl7.org/fhir/title-type",
            "code" : "short-title",
            "display" : "Short title"
          }
        ]
      },
      "value" : "2型糖尿病患者への投与"
    }
  ],
  "status" : "active",
  "phase" : {
    "coding" : [
      {
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code" : "C15602",
        "display" : "Phase III Trial"
      }
    ]
  },
  "recruitment" : {
    "eligibility" : {
      🔗 "reference" : "Group/JPMA0001-Criteria-JPN"
    }
  }
}