<?xml version="1.0" encoding="UTF-8"?>
<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 value="&lt;div xmlns=&quot;http://www.w3.org/1999/xhtml&quot;&gt;&lt;p class=&quot;res-header-id&quot;&gt;&lt;b&gt;Generated Narrative: CodeSystem research-study-party-role&lt;/b&gt;&lt;/p&gt;&lt;a name=&quot;research-study-party-role&quot;&gt; &lt;/a&gt;&lt;a name=&quot;hcresearch-study-party-role&quot;&gt; &lt;/a&gt;&lt;div style=&quot;display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%&quot;&gt;&lt;p style=&quot;margin-bottom: 0px&quot;&gt;Last updated: 2025-11-14 20:54:02+0000&lt;/p&gt;&lt;/div&gt;&lt;p&gt;This case-sensitive code system &lt;code&gt;http://terminology.hl7.org/CodeSystem/research-study-party-role&lt;/code&gt; defines the following codes:&lt;/p&gt;&lt;table class=&quot;codes&quot;&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;&lt;b&gt;Code&lt;/b&gt;&lt;/td&gt;&lt;td&gt;&lt;b&gt;Display&lt;/b&gt;&lt;/td&gt;&lt;td&gt;&lt;b&gt;Definition&lt;/b&gt;&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;sponsor&lt;a name=&quot;research-study-party-role-sponsor&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Sponsor&lt;/td&gt;&lt;td&gt;Person, company, agency or institution that initiates a clinical investigation      and takes responsibility for that investigation but does not conduct the investigation.&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;lead-sponsor&lt;a name=&quot;research-study-party-role-lead-sponsor&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Lead sponsor&lt;/td&gt;&lt;td&gt;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.&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;sponsor-investigator&lt;a name=&quot;research-study-party-role-sponsor-investigator&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Sponsor-investigator&lt;/td&gt;&lt;td&gt;Entity who both initiates and conducts an investigation.&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;primary-investigator&lt;a name=&quot;research-study-party-role-primary-investigator&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Principal investigator&lt;/td&gt;&lt;td&gt;An investigator who is responsible for all aspects of the conduct of a study.&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;collaborator&lt;a name=&quot;research-study-party-role-collaborator&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Collaborator&lt;/td&gt;&lt;td&gt;An organization or individual, who contributes to a study by providing support      to the primary investigator to conduct research.&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;funding-source&lt;a name=&quot;research-study-party-role-funding-source&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Funding source&lt;/td&gt;&lt;td&gt;An organization that underwrites financial support for the research study.&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;general-contact&lt;a name=&quot;research-study-party-role-general-contact&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;General contact&lt;/td&gt;&lt;td&gt;Information for the person who can answer general questions for a study.&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;recruitment-contact&lt;a name=&quot;research-study-party-role-recruitment-contact&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Recruitment contact&lt;/td&gt;&lt;td&gt;Information for the person who can answer recruitment questions for a study.&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;sub-investigator&lt;a name=&quot;research-study-party-role-sub-investigator&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Sub-investigator&lt;/td&gt;&lt;td&gt;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).&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;study-chair&lt;a name=&quot;research-study-party-role-study-chair&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Study chair&lt;/td&gt;&lt;td&gt;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)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;irb&lt;a name=&quot;research-study-party-role-irb&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Institutional Review Board&lt;/td&gt;&lt;td&gt;A group of individuals that reviews and monitors research involving human subjects.&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td style=&quot;white-space:nowrap&quot;&gt;data-monitoring&lt;a name=&quot;research-study-party-role-data-monitoring&quot;&gt; &lt;/a&gt;&lt;/td&gt;&lt;td&gt;Data Monitoring&lt;/td&gt;&lt;td&gt;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).&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;&lt;/div&gt;"/>
  </text>
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    <valueCode value="brr"/>
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  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/>
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  <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&apos;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>