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 - English Language

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    {
      "resourceType" : "ResearchStudy",
      "id" : "JPMA0001-eng",
      "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-eng</b></p><a name=\"JPMA0001-eng\"> </a><a name=\"hcJPMA0001-eng\"> </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>identifier</b>: Sponsor Identifier/JPMA001\u00a0(use:\u00a0usual,\u00a0)</p><p><b>version</b>: 2.0</p><p><b>title</b>: A Multicenter, 52-week, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Co-administration of JPMA001 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control Treated With Oral Hypoglycemic Drugs as a Single Agent</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>Administration for patients with type 2 diabetes</td></tr></table><p><b>date</b>: 2026-01-14</p><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></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"
        }
      ],
      "identifier" : [
        {
          "use" : "usual",
          "type" : {
            "text" : "Sponsor Identifier"
          },
          "system" : "https://exemplarSponsor.com/sponsor-identifier",
          "value" : "JPMA001"
        }
      ],
      "version" : "2.0",
      "title" : "A Multicenter, 52-week, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Co-administration of JPMA001 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control Treated With Oral Hypoglycemic Drugs as a Single Agent",
      "label" : [
        {
          "type" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/title-type",
                "code" : "short-title",
                "display" : "Short title"
              }
            ]
          },
          "value" : "Administration for patients with type 2 diabetes"
        }
      ],
      "date" : "2026-01-14",
      "status" : "active",
      "phase" : {
        "coding" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C15602",
            "display" : "Phase III Trial"
          }
        ]
      }
    }