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| CodeSystem |
| hl7.fhir.uv.clinical-study-protocol#current | Thesaurus.owl | Fragment of NCIT Code System |
Narrative
Note: links and images are rebased to the (stated) source
- Include these codes as defined in
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2| Code | Display | Definition |
| C70793 | Clinical Study Sponsor | An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary) |
| C215670 | Local Legal Sponsor | The sponsor's legal representative at a geographical region within which the sponsor has no legal presence. (ICH M11) |
| C71136 | Regulatory Application Sponsor | The party who submits a marketing application to FDA for approval of a drug, device, or biologic product. An applicant is the person or entity who assumes responsibility for the marketing of a new medical product, including responsibility for compliance with applicable provisions of the Federal Food, Drug, and Cosmetic Act and related regulations. The sponsor is usually an individual, partnership, corporation, government agency, manufacturer or scientific institution. |
| C142679 | Secondary Sponsor | Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on sponsorship responsibilities. (WHO) |
| C215669 | Study Co-Sponsor | An individual, company, institution, or organization that is designated by the study sponsor as a vested partner in the study. |
| C93478 | Study Legal Sponsor | A sponsor that initiates the investigation and is legally responsible for the study. |
| C156625 | Device Manufacturer | A person or entity that designs, manufactures, fabricates, assembles, or processes a finished device. |
| C51876 | Sponsor Medical Expert | A physician or health care provider selected by the sponsor to be readily available to advise clinical trial officials on trial related medical questions or problems. |
Source1
{
"resourceType": "ValueSet",
"id": "udp-party-role-type-vs",
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 1
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use",
"_valueCode": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
}
]
}
}
],
"url": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs",
"version": "1.0.0-ballot2",
"name": "UDPPartyRoleType",
"title": "UDP Party Role Type Value Set",
"status": "active",
"experimental": false,
"date": "2026-03-30T16:32:09+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"contact": [
{
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim"
},
{
"system": "email",
"value": "UDP@HL7Vulcan.org"
}
]
}
],
"description": "These codes represent the types of role ResearchStudy.AssociatedParty can play.\nThis is a UDP specific value set.",
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "001",
"display": "World"
}
]
}
],
"compose": {
"include": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"concept": [
{
"code": "C70793",
"display": "Clinical Study Sponsor"
},
{
"code": "C215670",
"display": "Local Legal Sponsor"
},
{
"code": "C71136",
"display": "Regulatory Application Sponsor"
},
{
"code": "C142679",
"display": "Secondary Sponsor"
},
{
"code": "C215669",
"display": "Study Co-Sponsor"
},
{
"code": "C93478",
"display": "Study Legal Sponsor"
},
{
"code": "C156625",
"display": "Device Manufacturer"
},
{
"code": "C51876",
"display": "Sponsor Medical Expert"
}
]
}
]
}
}
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