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| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemResearchStudyPartyRole
{
"resourceType" : "CodeSystem",
"id" : "research-study-party-role",
"meta" : {
"lastUpdated" : "2025-10-26T05:47:02+00:00",
"profile" : ["http://hl7.org/fhir/StructureDefinition/shareablecodesystem"]
},
"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: 2022-05-12T12:40:00Z</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"shareablecodesystem.html\">Shareable CodeSystem</a></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>"
},
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 0
}],
"url" : "http://hl7.org/fhir/research-study-party-role",
"identifier" : [{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.4.1968"
}],
"version" : "6.0.0-ballot3",
"name" : "ResearchStudyPartyRole",
"title" : "Research Study Party Role",
"status" : "active",
"experimental" : false,
"date" : "2022-05-12T12:40:00+00:00",
"publisher" : "HL7 (FHIR Project)",
"contact" : [{
"telecom" : [{
"system" : "url",
"value" : "http://hl7.org/fhir"
},
{
"system" : "email",
"value" : "fhir@lists.hl7.org"
}]
}],
"description" : "This is a ResearchStudy's party role.",
"jurisdiction" : [{
"coding" : [{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}]
}],
"caseSensitive" : true,
"valueSet" : "http://hl7.org/fhir/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)."
}]
}
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot3 generated on Sun, Oct 26, 2025 05:49+0000.
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