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

: UDP Party Role Type Value Set

Page standards status: Trial-use Maturity Level: 1

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="udp-party-role-type-vs"/>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <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 &#x1F4E6;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>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs"/>
  <version value="1.0.0-ballot2"/>
  <name value="UDPPartyRoleType"/>
  <title value="UDP Party Role Type Value Set"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-04-02T08:57:07+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="UDP@HL7Vulcan.org"/>
    </telecom>
  </contact>
  <description
               value="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."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
        <code value="C70793"/>
        <display value="Clinical Study Sponsor"/>
      </concept>
      <concept>
        <code value="C215670"/>
        <display value="Local Legal Sponsor"/>
      </concept>
      <concept>
        <code value="C71136"/>
        <display value="Regulatory Application Sponsor"/>
      </concept>
      <concept>
        <code value="C142679"/>
        <display value="Secondary Sponsor"/>
      </concept>
      <concept>
        <code value="C215669"/>
        <display value="Study Co-Sponsor"/>
      </concept>
      <concept>
        <code value="C93478"/>
        <display value="Study Legal Sponsor"/>
      </concept>
      <concept>
        <code value="C156625"/>
        <display value="Device Manufacturer"/>
      </concept>
      <concept>
        <code value="C51876"/>
        <display value="Sponsor Medical Expert"/>
      </concept>
    </include>
  </compose>
</ValueSet>