<?xml version="1.0" encoding="UTF-8"?><CodeSystem xmlns="http://hl7.org/fhir"><id value="research-study-party-role"/><meta><lastUpdated value="2026-04-03T20:06:10+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: 2022-05-12T12:40:00Z</p></div><p>This case-sensitive code system <code>http://hl7.org/fhir/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-standards-status"><valueCode value="informative"/></extension><extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"><valueInteger value="0"/></extension><url value="http://hl7.org/fhir/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="6.0.0-ballot4"/><name value="ResearchStudyPartyRole"/><title value="Research Study Party Role"/><status value="active"/><experimental value="false"/><date value="2022-05-12T12:40:00+00:00"/><publisher value="HL7 (FHIR Project)"/><contact><telecom><system value="url"/><value value="http://hl7.org/fhir"/></telecom><telecom><system value="email"/><value value="fhir@lists.hl7.org"/></telecom></contact><description value="This is a ResearchStudy's party role."/><jurisdiction><coding><system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/><code value="001"/><display value="World"/></coding></jurisdiction><caseSensitive value="true"/><valueSet value="http://hl7.org/fhir/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>