{
"resourceType": "CodeSystem",
"id": "research-study-party-role",
"meta": {
"lastUpdated": "2025-11-14T20:54:02+00:00"
},
"text": {
"status": "generated",
"div": "<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>"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 1
}
],
"url": "http://terminology.hl7.org/CodeSystem/research-study-party-role",
"identifier": [
{
"system": "urn:ietf:rfc:3986",
"value": "urn:oid:2.16.840.1.113883.4.642.4.1968"
}
],
"version": "1.0.0",
"name": "ResearchStudyPartyRole",
"title": "Research Study Party Role",
"status": "active",
"experimental": false,
"date": "2025-11-14T12:40:00+00:00",
"publisher": "Health Level Seven International",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "http://hl7.org"
},
{
"system": "email",
"value": "hq@HL7.org"
}
]
}
],
"description": "This is a ResearchStudy's party role.",
"copyright": "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": true,
"valueSet": "http://terminology.hl7.org/ValueSet/research-study-party-role",
"content": "complete",
"concept": [
{
"code": "sponsor",
"display": "Sponsor",
"definition": "Person, company, agency or institution that initiates a clinical investigation and takes responsibility for that investigation but does not conduct the investigation."
},
{
"code": "lead-sponsor",
"display": "Lead sponsor",
"definition": "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."
},
{
"code": "sponsor-investigator",
"display": "Sponsor-investigator",
"definition": "Entity who both initiates and conducts an investigation."
},
{
"code": "primary-investigator",
"display": "Principal investigator",
"definition": "An investigator who is responsible for all aspects of the conduct of a study."
},
{
"code": "collaborator",
"display": "Collaborator",
"definition": "An organization or individual, who contributes to a study by providing support to the primary investigator to conduct research."
},
{
"code": "funding-source",
"display": "Funding source",
"definition": "An organization that underwrites financial support for the research study."
},
{
"code": "general-contact",
"display": "General contact",
"definition": "Information for the person who can answer general questions for a study."
},
{
"code": "recruitment-contact",
"display": "Recruitment contact",
"definition": "Information for the person who can answer recruitment questions for a study."
},
{
"code": "sub-investigator",
"display": "Sub-investigator",
"definition": "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)."
},
{
"code": "study-chair",
"display": "Study chair",
"definition": "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)"
},
{
"code": "irb",
"display": "Institutional Review Board",
"definition": "A group of individuals that reviews and monitors research involving human subjects."
},
{
"code": "data-monitoring",
"display": "Data Monitoring",
"definition": "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)."
}
]
}