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

## : START HERE: Exemplar Research Study with narrative

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    {
      "resourceType" : "ResearchStudy",
      "id" : "Exemplar-ResearchStudy-001",
      "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 Exemplar-ResearchStudy-001</b></p><a name=\"Exemplar-ResearchStudy-001\"> </a><a name=\"hcExemplar-ResearchStudy-001\"> </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><p><b>M11_ConfidentialityStatement</b>: All data is confidential</p><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 C218488}\">Protocol Previously Amended See Summary of Changes Before the Table of Contents</span></li><li>versionDate: 2017-10-01</li></ul></blockquote><blockquote><p><b>M11_Approval</b></p><ul><li>approvalDate: 2017-10-05</li><li>signature: No display for Signature  (data:  )</li><li>signatureUrl: <a href=\"https://somelocation\">https://somelocation</a></li><li>signatureMethod: electronic and wet ink copy</li></ul></blockquote><p><b>Narrative Elements</b>: <a href=\"Composition-Exemplar-Narrative.html\">Composition Exemplar Protocol Narratives</a></p><p><b>Narrative Elements</b>: <a href=\"Composition-Exemplar-Narrative-2.1.html\">Composition Exemplar Protocol Narrative 2.1</a></p><p><b>identifier</b>: Sponsor Protocol Identifier/ABC-Exemplar, EU CT Number/EU-1234, Other Regulatory or Clinical Trial Identifier/ERA1234, Amendment Identifier/ABC-Exemplar(a)</p><p><b>version</b>: (a)</p><p><b>title</b>: A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus</p><blockquote><p><b>label</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C207646}\">Study Acronym</span></p><p><b>value</b>: Inhaled vs IM Exoticillin</p></blockquote><blockquote><p><b>label</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C207615}\">Brief Study Title</span></p><p><b>value</b>: A Phase 3 Study of Inhaled versus Intramuscular Exoticillin for Bronchtis in Diabetic Japanese Patients</p></blockquote><h3>RelatesTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Target[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Justification</td><td><a href=\"ResearchStudy-Exemplar-ResearchStudy-Current-Amendment.html\">ResearchStudy: extension = ,,; identifier = Sponsor Protocol Identifier: ABC-Exemplar\u00a0(use:\u00a0usual,\u00a0); version = (a); status = active</a></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>Focus</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"MedicinalProductDefinition-Exemplar-MedicinalProduct.html\">MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code: EX2015/03</a></td></tr></table><p><b>condition</b>: <span title=\"Codes:{http://snomed.info/sct 1137328006}\">Iatrogenic hypoglycaemia</span></p><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C70793}\">Clinical Study Sponsor</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-Sponsor-Organization.html\">Organization Exemplar Pharmaceuticals Co.</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C70793}\">Clinical Study Sponsor</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-Sponsor-Practitioner.html\">Practitioner Dr Exemplar Practitioner</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215669}\">Study Co-Sponsor</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-CoSponsor-Organization.html\">Organization Exemplar Pharmazeutika GmBH.</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215669}\">Study Co-Sponsor</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-CoSponsor-Practitioner.html\">Practitioner Dr Exemplar von Practitioner</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215670}\">Local Legal Sponsor</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-Local-Sponsor-Organization.html\">Organization Fictive Pharmaceuticals (Australia) Pty</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215670}\">Local Legal Sponsor</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-Local-Sponsor-Practitioner.html\">Practitioner Bruce Exemplar</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C156625}\">Device Manufacturer</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-Devices-Organization.html\">Organization Exemplar Devices Ltd</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C51876}\">Sponsor Medical Expert</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-Sponsor-Expert-Practitioner.html\">Practitioner Dr Exemplar Consultant</a></p></blockquote></div>"
      },
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement",
          "valueString" : "All data is confidential"
        },
        {
          "extension" : [
            {
              "url" : "originalProtocol",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                    "code" : "C218488",
                    "display" : "Protocol Previously Amended See Summary of Changes Before the Table of Contents"
                  }
                ]
              }
            },
            {
              "url" : "versionDate",
              "valueDate" : "2017-10-01"
            }
          ],
          "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"
        },
        {
          "extension" : [
            {
              "url" : "approvalDate",
              "valueDate" : "2017-10-05"
            },
            {
              "url" : "signature",
              "valueSignature" : {
                "data" : " "
              }
            },
            {
              "url" : "signatureUrl",
              "valueUrl" : "https://somelocation"
            },
            {
              "url" : "signatureMethod",
              "valueString" : "electronic and wet ink copy"
            }
          ],
          "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
        },
        {
          "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements",
          "valueReference" : {
            🔗 "reference" : "Composition/Exemplar-Narrative"
          }
        },
        {
          "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements",
          "valueReference" : {
            🔗 "reference" : "Composition/Exemplar-Narrative-2.1"
          }
        }
      ],
      "identifier" : [
        {
          "type" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C132351",
                "display" : "Sponsor Protocol Identifier"
              }
            ]
          },
          "system" : "https://exemplarSponsor.com/sponsor-identifier",
          "value" : "ABC-Exemplar"
        },
        {
          "type" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218684"
              }
            ],
            "text" : "EU CT Number"
          },
          "system" : "https://exemplarEMA.org/registry-identifier",
          "value" : "EU-1234"
        },
        {
          "type" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218690"
              }
            ],
            "text" : "Other Regulatory or Clinical Trial Identifier"
          },
          "system" : "https://exemplarRegulator.org/registry-identifier",
          "value" : "ERA1234",
          "assigner" : {
            🔗 "reference" : "Organization/Exemplar-Regulator-Organization"
          }
        },
        {
          "type" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C218477"
              }
            ],
            "text" : "Amendment Identifier"
          },
          "system" : "https://example.org/amendment-identifier",
          "value" : "ABC-Exemplar(a)"
        }
      ],
      "version" : "(a)",
      "title" : "A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus",
      "label" : [
        {
          "type" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C207646",
                "display" : "Study Acronym"
              }
            ]
          },
          "value" : "Inhaled vs IM Exoticillin"
        },
        {
          "type" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C207615",
                "display" : "Brief Study Title"
              }
            ]
          },
          "value" : "A Phase 3 Study of Inhaled versus Intramuscular Exoticillin for Bronchtis in Diabetic Japanese Patients"
        }
      ],
      "relatesTo" : [
        {
          "type" : "justification",
          "targetReference" : {
            🔗 "reference" : "ResearchStudy/Exemplar-ResearchStudy-Current-Amendment"
          }
        }
      ],
      "status" : "active",
      "phase" : {
        "coding" : [
          {
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C15602",
            "display" : "Phase III Trial"
          }
        ]
      },
      "focus" : [
        {
          "reference" : {
            🔗 "reference" : "MedicinalProductDefinition/Exemplar-MedicinalProduct"
          }
        }
      ],
      "condition" : [
        {
          "coding" : [
            {
              "system" : "http://snomed.info/sct",
              "code" : "1137328006",
              "display" : "Iatrogenic hypoglycaemia"
            }
          ]
        }
      ],
      "associatedParty" : [
        {
          "role" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C70793",
                "display" : "Clinical Study Sponsor"
              }
            ]
          },
          "party" : {
            🔗 "reference" : "Organization/Exemplar-Sponsor-Organization"
          }
        },
        {
          "role" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C70793",
                "display" : "Clinical Study Sponsor"
              }
            ]
          },
          "party" : {
            🔗 "reference" : "Practitioner/Exemplar-Sponsor-Practitioner"
          }
        },
        {
          "role" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C215669",
                "display" : "Study Co-Sponsor"
              }
            ]
          },
          "party" : {
            🔗 "reference" : "Organization/Exemplar-CoSponsor-Organization"
          }
        },
        {
          "role" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C215669",
                "display" : "Study Co-Sponsor"
              }
            ]
          },
          "party" : {
            🔗 "reference" : "Practitioner/Exemplar-CoSponsor-Practitioner"
          }
        },
        {
          "role" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C215670",
                "display" : "Local Legal Sponsor"
              }
            ]
          },
          "party" : {
            🔗 "reference" : "Organization/Exemplar-Local-Sponsor-Organization"
          }
        },
        {
          "role" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C215670",
                "display" : "Local Legal Sponsor"
              }
            ]
          },
          "party" : {
            🔗 "reference" : "Practitioner/Exemplar-Local-Sponsor-Practitioner"
          }
        },
        {
          "role" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C156625",
                "display" : "Device Manufacturer"
              }
            ]
          },
          "party" : {
            🔗 "reference" : "Organization/Exemplar-Devices-Organization"
          }
        },
        {
          "role" : {
            "coding" : [
              {
                "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code" : "C51876",
                "display" : "Sponsor Medical Expert"
              }
            ]
          },
          "party" : {
            🔗 "reference" : "Practitioner/Exemplar-Sponsor-Expert-Practitioner"
          }
        }
      ]
    }