FHIR IG analytics| Package | hl7.fhir.uv.clinical-study-protocol |
| Resource Type | ResearchStudy |
| Id | ResearchStudy-JPMA0001-jpn.json |
| FHIR Version | R6 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: ResearchStudy JPMA0001-jpn
Language: en
Profile: M11 Research Study Profile
M11 Research Study Extension
- originalProtocol: Protocol Not Amended
- versionDate: 2026-01-14
Narrative Elements: Composition JPMA0001 Protocol Narrative Sections 5.2 and 5.3 (Inclusion/Exclusion Ctriteria)
identifier: Sponsor Identifier/JPMA001 (use: usual, )
version: 2.0
title: 経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として,JPMA001を併用投与した時の安全性および有効性を検討する多施設共同,52週間,ランダム化,並行群間試験
| Type | Value |
| Short title | 2型糖尿病患者への投与 |
status: Active
phase: Phase III Trial
| Eligibility |
| Group Japanese Protocol from Vulcan UDP Eligibility Criteria |
{
"resourceType": "ResearchStudy",
"id": "JPMA0001-jpn",
"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": [
{
"extension": [
{
"url": "originalProtocol",
"valueCodeableConcept": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218485",
"display": "Protocol Not Amended"
}
]
}
},
{
"url": "versionDate",
"valueDate": "2026-01-14"
}
],
"url": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"
},
{
"url": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements",
"valueReference": {
"reference": "Composition/JPMA0001-Section5-jpn"
}
}
],
"identifier": [
{
"use": "usual",
"type": {
"text": "Sponsor Identifier"
},
"system": "https://exemplarSponsor.com/sponsor-identifier",
"value": "JPMA001"
}
],
"version": "2.0",
"title": "経口血糖降下薬単剤による治療では血糖コントロール不十分な2型糖尿病患者を対象として,JPMA001を併用投与した時の安全性および有効性を検討する多施設共同,52週間,ランダム化,並行群間試験",
"label": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/title-type",
"code": "short-title",
"display": "Short title"
}
]
},
"value": "2型糖尿病患者への投与"
}
],
"status": "active",
"phase": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C15602",
"display": "Phase III Trial"
}
]
},
"recruitment": {
"eligibility": {
"reference": "Group/JPMA0001-Criteria-JPN"
}
}
}