--- type: "codesystem" title: "Research Study Party Role" codesystem: "research-study-party-role" --- # Research Study Party Role - **Official URL**: http://hl7.org/fhir/research-study-party-role - **Version**: 6.0.0 - **Status**: active - **Name**: ResearchStudyPartyRole - **Title**: Research Study Party Role - **Publisher**: HL7 (FHIR Project) - **Description**: This is a ResearchStudy's party role. - **Case Sensitive**: true - **Content**: complete ## Concepts | Code | Display | Definition | | --- | --- | --- | | sponsor | Sponsor | Person, company, agency or institution that initiates a clinical investigation and takes responsibility for that investigation but does not conduct the investigation. | | lead-sponsor | Lead sponsor | 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. | | sponsor-investigator | Sponsor-investigator | Entity who both initiates and conducts an investigation. | | primary-investigator | Principal investigator | An investigator who is responsible for all aspects of the conduct of a study. | | collaborator | Collaborator | An organization or individual, who contributes to a study by providing support to the primary investigator to conduct research. | | funding-source | Funding source | An organization that underwrites financial support for the research study. | | general-contact | General contact | Information for the person who can answer general questions for a study. | | recruitment-contact | Recruitment contact | Information for the person who can answer recruitment questions for a study. | | sub-investigator | Sub-investigator | 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). | | study-chair | Study chair | 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) | | irb | Institutional Review Board | A group of individuals that reviews and monitors research involving human subjects. | | data-monitoring | Data Monitoring | 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). | ## CodeSystem XML ```xml <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."/> <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> ```