FHIR IG analytics| Package | hl7.fhir.uv.clinical-study-protocol |
| Resource Type | ResearchStudy |
| Id | ResearchStudy-Exemplar-ResearchStudy-001.json |
| FHIR Version | R6 |
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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
| Type | Target[x] |
| Justification | ResearchStudy: extension = ,,; identifier = Sponsor Protocol Identifier: ABC-Exemplar (use: usual, ); version = (a); status = active |
status: Active
phase: Phase III Trial
| Reference |
| MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code: EX2015/03 |
condition: Iatrogenic hypoglycaemia
associatedParty
role: Clinical Study Sponsor
associatedParty
role: Clinical Study Sponsor
associatedParty
role: Study Co-Sponsor
associatedParty
role: Study Co-Sponsor
associatedParty
role: Local Legal Sponsor
associatedParty
role: Local Legal Sponsor
party: Practitioner Bruce Exemplar
associatedParty
role: Device Manufacturer
associatedParty
role: Sponsor Medical Expert
{
"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": {
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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",
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"display": "Clinical Study Sponsor"
}
]
},
"party": {
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}
},
{
"role": {
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{
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"display": "Clinical Study Sponsor"
}
]
},
"party": {
"reference": "Practitioner/Exemplar-Sponsor-Practitioner"
}
},
{
"role": {
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{
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}
]
},
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}
},
{
"role": {
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{
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"code": "C215669",
"display": "Study Co-Sponsor"
}
]
},
"party": {
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}
},
{
"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"
}
}
]
}