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Packagehl7.fhir.uv.clinical-study-protocol
Resource TypeResearchStudy
IdResearchStudy-Exemplar-ResearchStudy-001.json
FHIR VersionR6

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ResearchStudy Exemplar-ResearchStudy-001

Language: en

Profile: M11 Research Study Profile

M11_ConfidentialityStatement: All data is confidential

M11 Research Study Extension

  • originalProtocol: Protocol Previously Amended See Summary of Changes Before the Table of Contents
  • versionDate: 2017-10-01

M11_Approval

  • approvalDate: 2017-10-05
  • signature: No display for Signature (data: 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)
  • signatureUrl: https://somelocation
  • signatureMethod: electronic and wet ink copy

Narrative Elements: Composition Exemplar Protocol Narratives

Narrative Elements: Composition Exemplar Protocol Narrative 2.1

identifier: Sponsor Protocol Identifier/ABC-Exemplar, EU CT Number/EU-1234, Other Regulatory or Clinical Trial Identifier/ERA1234, Amendment Identifier/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: Study Acronym

value: Inhaled vs IM Exoticillin

label

type: Brief Study Title

value: A Phase 3 Study of Inhaled versus Intramuscular Exoticillin for Bronchtis in Diabetic Japanese Patients

RelatesTos

-TypeTarget[x]
*JustificationResearchStudy: extension = ,,; identifier = Sponsor Protocol Identifier: ABC-Exemplar (use: usual, ); version = (a); status = active

status: Active

phase: Phase III Trial

Focus

-Reference
*MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code: EX2015/03

condition: Iatrogenic hypoglycaemia

associatedParty

role: Clinical Study Sponsor

party: Organization Exemplar Pharmaceuticals Co.

associatedParty

role: Clinical Study Sponsor

party: Practitioner Dr Exemplar Practitioner

associatedParty

role: Study Co-Sponsor

party: Organization Exemplar Pharmazeutika GmBH.

associatedParty

role: Study Co-Sponsor

party: Practitioner Dr Exemplar von Practitioner

associatedParty

role: Local Legal Sponsor

party: Organization Fictive Pharmaceuticals (Australia) Pty

associatedParty

role: Local Legal Sponsor

party: Practitioner Bruce Exemplar

associatedParty

role: Device Manufacturer

party: Organization Exemplar Devices Ltd

associatedParty

role: Sponsor Medical Expert

party: Practitioner Dr Exemplar Consultant


Source1

{
  "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": "<!-- snip (see above) -->"
  },
  "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": "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"
          }
        },
        {
          "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"
      }
    }
  ]
}