HL7 Terminology (THO)
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HL7 Terminology (THO), published by HL7 International - Vocabulary Work Group. This guide is not an authorized publication; it is the continuous build for version 7.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/UTG/ and changes regularly. See the Directory of published versions

: Research Study Party Role - XML Representation

Active as of 2025-11-14 Maturity Level: 1

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-party-role"/>
  <meta>
    <lastUpdated value="2025-11-14T20:54:02+00:00"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem research-study-party-role</b></p><a name="research-study-party-role"> </a><a name="hcresearch-study-party-role"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Last updated: 2025-11-14 20:54:02+0000</p></div><p>This case-sensitive code system <code>http://terminology.hl7.org/CodeSystem/research-study-party-role</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">sponsor<a name="research-study-party-role-sponsor"> </a></td><td>Sponsor</td><td>Person, company, agency or institution that initiates a clinical investigation      and takes responsibility for that investigation but does not conduct the investigation.</td></tr><tr><td style="white-space:nowrap">lead-sponsor<a name="research-study-party-role-lead-sponsor"> </a></td><td>Lead sponsor</td><td>Primary person, company, agency or institution that initiates a clinical investigation      and takes responsibility for that investigation but does not conduct the investigation      if there is more than one sponsor.</td></tr><tr><td style="white-space:nowrap">sponsor-investigator<a name="research-study-party-role-sponsor-investigator"> </a></td><td>Sponsor-investigator</td><td>Entity who both initiates and conducts an investigation.</td></tr><tr><td style="white-space:nowrap">primary-investigator<a name="research-study-party-role-primary-investigator"> </a></td><td>Principal investigator</td><td>An investigator who is responsible for all aspects of the conduct of a study.</td></tr><tr><td style="white-space:nowrap">collaborator<a name="research-study-party-role-collaborator"> </a></td><td>Collaborator</td><td>An organization or individual, who contributes to a study by providing support      to the primary investigator to conduct research.</td></tr><tr><td style="white-space:nowrap">funding-source<a name="research-study-party-role-funding-source"> </a></td><td>Funding source</td><td>An organization that underwrites financial support for the research study.</td></tr><tr><td style="white-space:nowrap">general-contact<a name="research-study-party-role-general-contact"> </a></td><td>General contact</td><td>Information for the person who can answer general questions for a study.</td></tr><tr><td style="white-space:nowrap">recruitment-contact<a name="research-study-party-role-recruitment-contact"> </a></td><td>Recruitment contact</td><td>Information for the person who can answer recruitment questions for a study.</td></tr><tr><td style="white-space:nowrap">sub-investigator<a name="research-study-party-role-sub-investigator"> </a></td><td>Sub-investigator</td><td>Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).</td></tr><tr><td style="white-space:nowrap">study-chair<a name="research-study-party-role-study-chair"> </a></td><td>Study chair</td><td>An individual person who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. (Also called study director or study chairperson)</td></tr><tr><td style="white-space:nowrap">irb<a name="research-study-party-role-irb"> </a></td><td>Institutional Review Board</td><td>A group of individuals that reviews and monitors research involving human subjects.</td></tr><tr><td style="white-space:nowrap">data-monitoring<a name="research-study-party-role-data-monitoring"> </a></td><td>Data Monitoring</td><td>An organization or individual who monitors the validity and integrity of collected data while prioritizing participant safety and study integrity. The organization may be called a Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB).</td></tr></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
  </extension>
  <url
       value="http://terminology.hl7.org/CodeSystem/research-study-party-role"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.4.1968"/>
  </identifier>
  <version value="1.0.0"/>
  <name value="ResearchStudyPartyRole"/>
  <title value="Research Study Party Role"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2025-11-14T12:40:00+00:00"/>
  <publisher value="Health Level Seven International"/>
  <contact>
    <telecom>
      <system value="url"/>
      <value value="http://hl7.org"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="hq@HL7.org"/>
    </telecom>
  </contact>
  <description value="This is a ResearchStudy's party role."/>
  <copyright
             value="This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license"/>
  <caseSensitive value="true"/>
  <valueSet
            value="http://terminology.hl7.org/ValueSet/research-study-party-role"/>
  <content value="complete"/>
  <concept>
    <code value="sponsor"/>
    <display value="Sponsor"/>
    <definition
                value="Person, company, agency or institution that initiates a clinical investigation      and takes responsibility for that investigation but does not conduct the investigation."/>
  </concept>
  <concept>
    <code value="lead-sponsor"/>
    <display value="Lead sponsor"/>
    <definition
                value="Primary person, company, agency or institution that initiates a clinical investigation      and takes responsibility for that investigation but does not conduct the investigation      if there is more than one sponsor."/>
  </concept>
  <concept>
    <code value="sponsor-investigator"/>
    <display value="Sponsor-investigator"/>
    <definition
                value="Entity who both initiates and conducts an investigation."/>
  </concept>
  <concept>
    <code value="primary-investigator"/>
    <display value="Principal investigator"/>
    <definition
                value="An investigator who is responsible for all aspects of the conduct of a study."/>
  </concept>
  <concept>
    <code value="collaborator"/>
    <display value="Collaborator"/>
    <definition
                value="An organization or individual, who contributes to a study by providing support      to the primary investigator to conduct research."/>
  </concept>
  <concept>
    <code value="funding-source"/>
    <display value="Funding source"/>
    <definition
                value="An organization that underwrites financial support for the research study."/>
  </concept>
  <concept>
    <code value="general-contact"/>
    <display value="General contact"/>
    <definition
                value="Information for the person who can answer general questions for a study."/>
  </concept>
  <concept>
    <code value="recruitment-contact"/>
    <display value="Recruitment contact"/>
    <definition
                value="Information for the person who can answer recruitment questions for a study."/>
  </concept>
  <concept>
    <code value="sub-investigator"/>
    <display value="Sub-investigator"/>
    <definition
                value="Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows)."/>
  </concept>
  <concept>
    <code value="study-chair"/>
    <display value="Study chair"/>
    <definition
                value="An individual person who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. (Also called study director or study chairperson)"/>
  </concept>
  <concept>
    <code value="irb"/>
    <display value="Institutional Review Board"/>
    <definition
                value="A group of individuals that reviews and monitors research involving human subjects."/>
  </concept>
  <concept>
    <code value="data-monitoring"/>
    <display value="Data Monitoring"/>
    <definition
                value="An organization or individual who monitors the validity and integrity of collected data while prioritizing participant safety and study integrity. The organization may be called a Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB)."/>
  </concept>
</CodeSystem>