# START HERE: Exemplar Research Study with narrative - Clinical Study Protocol v1.0.0-ballot2

## Example ResearchStudy: START HERE: Exemplar Research Study with narrative

Language: en

Profile: [M11 Research Study Profile](StructureDefinition-m11-research-study-profile.md)

**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:  )
* signatureUrl: [https://somelocation](https://somelocation)
* signatureMethod: electronic and wet ink copy

**Narrative Elements**: [Composition Exemplar Protocol Narratives](Composition-Exemplar-Narrative.md)

**Narrative Elements**: [Composition Exemplar Protocol Narrative 2.1](Composition-Exemplar-Narrative-2.1.md)

**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

| | | |
| :--- | :--- | :--- |
| - | **Type** | **Target[x]** |
| * | Justification | [ResearchStudy: extension = ,,; identifier = Sponsor Protocol Identifier: ABC-Exemplar (use: usual, ); version = (a); status = active](ResearchStudy-Exemplar-ResearchStudy-Current-Amendment.md) |

**status**: Active

**phase**: Phase III Trial

### Focus

| | |
| :--- | :--- |
| - | **Reference** |
| * | [MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code: EX2015/03](MedicinalProductDefinition-Exemplar-MedicinalProduct.md) |

**condition**: Iatrogenic hypoglycaemia

> **associatedParty****role**: Clinical Study Sponsor**party**: [Organization Exemplar Pharmaceuticals Co.](Organization-Exemplar-Sponsor-Organization.md)

> **associatedParty****role**: Clinical Study Sponsor**party**: [Practitioner Dr Exemplar Practitioner](Practitioner-Exemplar-Sponsor-Practitioner.md)

> **associatedParty****role**: Study Co-Sponsor**party**: [Organization Exemplar Pharmazeutika GmBH.](Organization-Exemplar-CoSponsor-Organization.md)

> **associatedParty****role**: Study Co-Sponsor**party**: [Practitioner Dr Exemplar von Practitioner](Practitioner-Exemplar-CoSponsor-Practitioner.md)

> **associatedParty****role**: Local Legal Sponsor**party**: [Organization Fictive Pharmaceuticals (Australia) Pty](Organization-Exemplar-Local-Sponsor-Organization.md)

> **associatedParty****role**: Local Legal Sponsor**party**: [Practitioner Bruce Exemplar](Practitioner-Exemplar-Local-Sponsor-Practitioner.md)

> **associatedParty****role**: Device Manufacturer**party**: [Organization Exemplar Devices Ltd](Organization-Exemplar-Devices-Organization.md)

> **associatedParty****role**: Sponsor Medical Expert**party**: [Practitioner Dr Exemplar Consultant](Practitioner-Exemplar-Sponsor-Expert-Practitioner.md)



## Resource Content

```json
{
  "resourceType" : "ResearchStudy",
  "id" : "Exemplar-ResearchStudy-001",
  "meta" : {
    "profile" : ["http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"]
  },
  "language" : "en",
  "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"
    }
  }]
}

```
