<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>

Generated Narrative: CodeSystem research-study-party-role

Last updated: 2022-05-12T12:40:00Z

This case-sensitive code system http://hl7.org/fhir/research-study-party-role defines the following codes:

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).