{ "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" : "

Generated Narrative: ResearchStudy Exemplar-ResearchStudy-001

Language: en

Profile: M11 Research Study Profile

M11_ConfidentialityStatement: All data is confidential

M11 Research Study Extension

M11_Approval

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\u00a0(use:\u00a0usual,\u00a0); 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

" }, "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" } }] }