Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

ValueSet: UDP Party Role Type Value Set

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-02 Maturity Level: 1 Computable Name: UDPPartyRoleType

These codes represent the types of role ResearchStudy.AssociatedParty can play. This is required for the mechanism used by FHIR for associating one entity with another. This is a UDP specific value set and uses NCIT codes to create an appropriate FHIR value set.

References

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2
    CodeDisplayDefinition
    C70793Clinical Study SponsorAn individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary)
    C215670Local Legal SponsorThe sponsor's legal representative at a geographical region within which the sponsor has no legal presence. (ICH M11)
    C71136Regulatory Application SponsorThe 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.
    C142679Secondary SponsorAdditional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on sponsorship responsibilities. (WHO)
    C215669Study Co-SponsorAn individual, company, institution, or organization that is designated by the study sponsor as a vested partner in the study.
    C93478Study Legal SponsorA sponsor that initiates the investigation and is legally responsible for the study.
    C156625Device ManufacturerA person or entity that designs, manufactures, fabricates, assembles, or processes a finished device.
    C51876Sponsor Medical ExpertA 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.

 

Expansion

Expansion performed internally based on codesystem Fragment of NCIT Code System v1.0.0-ballot2 (CodeSystem)

This value set contains 8 concepts

SystemCodeDisplay (en)DefinitionJSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C70793Clinical Study SponsorAn individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary)
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C215670Local Legal SponsorThe sponsor's legal representative at a geographical region within which the sponsor has no legal presence. (ICH M11)
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C71136Regulatory Application SponsorThe 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.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C142679Secondary SponsorAdditional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on sponsorship responsibilities. (WHO)
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C215669Study Co-SponsorAn individual, company, institution, or organization that is designated by the study sponsor as a vested partner in the study.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C93478Study Legal SponsorA sponsor that initiates the investigation and is legally responsible for the study.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C156625Device ManufacturerA person or entity that designs, manufactures, fabricates, assembles, or processes a finished device.
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C51876Sponsor Medical ExpertA 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.

Description of the above table(s).