Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## : UDP Party Role Type Value Set

Page standards status: Trial-use | Maturity Level: 1

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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

     a fhir:ValueSet ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "udp-party-role-type-vs"] ; #
      fhir:language [ fhir:v "en"] ; #
      fhir:text [
    fhir:status [ fhir:v "extensions" ] ;
    fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet udp-party-role-type-vs</b></p><a name=\"udp-party-role-type-vs\"> </a><a name=\"hcudp-party-role-type-vs\"> </a><ul><li>Include these codes as defined in <a href=\"CodeSystem-ncit-cs.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><span title=\"Version is not explicitly stated, which means it is fixed to the version provided in this specification\"> version ?1.0.0-ballot2</span><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C70793\">C70793</a></td><td>Clinical Study Sponsor</td><td>An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary)</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C215670\">C215670</a></td><td>Local Legal Sponsor</td><td>The sponsor's legal representative at a geographical region within which the sponsor has no legal presence. (ICH M11)</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C71136\">C71136</a></td><td>Regulatory Application Sponsor</td><td>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.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C142679\">C142679</a></td><td>Secondary Sponsor</td><td>Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on sponsorship responsibilities. (WHO)</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C215669\">C215669</a></td><td>Study Co-Sponsor</td><td>An individual, company, institution, or organization that is designated by the study sponsor as a vested partner in the study.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C93478\">C93478</a></td><td>Study Legal Sponsor</td><td>A sponsor that initiates the investigation and is legally responsible for the study.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C156625\">C156625</a></td><td>Device Manufacturer</td><td>A person or entity that designs, manufactures, fabricates, assembles, or processes a finished device.</td></tr><tr><td><a href=\"CodeSystem-ncit-cs.html#ncit-cs-C51876\">C51876</a></td><td>Sponsor Medical Expert</td><td>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.</td></tr></table></li></ul></div>"^^rdf:XMLLiteral ]
      ] ; #
      fhir:extension ( [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm>     ] ;
    fhir:value [
    a fhir:Integer ;
    fhir:v 1     ]
      ] [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-wg>     ] ;
    fhir:value [
    a fhir:Code ;
    fhir:v "brr"     ]
      ] [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status>     ] ;
    fhir:value [
    a fhir:Code ;
    fhir:v "trial-use" ;
          ( fhir:extension [
    fhir:url [
    fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom>         ] ;
    fhir:value [
    a fhir:Canonical ;
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol>         ]       ] )     ]
      ] ) ; #
      fhir:url [
    fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs"^^xsd:anyURI ;
    fhir:l <http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs>
      ] ; #
      fhir:version [ fhir:v "1.0.0-ballot2"] ; #
      fhir:name [ fhir:v "UDPPartyRoleType"] ; #
      fhir:title [ fhir:v "UDP Party Role Type Value Set"] ; #
      fhir:status [ fhir:v "active"] ; #
      fhir:experimental [ fhir:v false] ; #
      fhir:date [ fhir:v "2026-04-09T17:15:23+10:00"^^xsd:dateTime] ; #
      fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
      fhir:contact ( [
    fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
        ( fhir:telecom [
    fhir:system [ fhir:v "url" ] ;
    fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] [
    fhir:system [ fhir:v "email" ] ;
    fhir:value [ fhir:v "UDP@HL7Vulcan.org" ]     ] )
      ] ) ; #
      fhir:description [ fhir:v "These codes represent the types of role ResearchStudy.AssociatedParty can play. This is required for the\nmechanism used by FHIR for associating one entity with another. This is a UDP specific value set and uses NCIT codes to \ncreate an appropriate FHIR value set."] ; #
      fhir:jurisdiction ( [
        ( fhir:coding [
    fhir:system [
    fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ;
    fhir:l <http://unstats.un.org/unsd/methods/m49/m49.htm>       ] ;
    fhir:code [ fhir:v "001" ] ;
    fhir:display [ fhir:v "World" ]     ] )
      ] ) ; #
      fhir:copyright [ fhir:v "Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. \nThe ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. \n\nCDISC publishes semantics for the ICH M11 protocol data elements and valid \nvalue sets. This terminology set is published and stored in the NCI Thesaurus \nSubset C217023 - ICH M11 Terminology \n(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) \n\nThe NCI Thesaurus is released under the CC BY 4.0 license\n\nFor more licensing information and links see: [licenses.html](licenses.html)"] ; #
      fhir:compose [
        ( fhir:include [
    fhir:system [
    fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
    fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>       ] ;
          ( fhir:concept [
    fhir:code [ fhir:v "C70793" ] ;
    fhir:display [ fhir:v "Clinical Study Sponsor" ]       ] [
    fhir:code [ fhir:v "C215670" ] ;
    fhir:display [ fhir:v "Local Legal Sponsor" ]       ] [
    fhir:code [ fhir:v "C71136" ] ;
    fhir:display [ fhir:v "Regulatory Application Sponsor" ]       ] [
    fhir:code [ fhir:v "C142679" ] ;
    fhir:display [ fhir:v "Secondary Sponsor" ]       ] [
    fhir:code [ fhir:v "C215669" ] ;
    fhir:display [ fhir:v "Study Co-Sponsor" ]       ] [
    fhir:code [ fhir:v "C93478" ] ;
    fhir:display [ fhir:v "Study Legal Sponsor" ]       ] [
    fhir:code [ fhir:v "C156625" ] ;
    fhir:display [ fhir:v "Device Manufacturer" ]       ] [
    fhir:code [ fhir:v "C51876" ] ;
    fhir:display [ fhir:v "Sponsor Medical Expert" ]       ] )     ] )
      ] . #