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

CodeSystem XML

<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-party-role"/>
  <meta>
    <lastUpdated value="2022-05-12T12:40:00+00:00"/>
  </meta>
  <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"/>
  <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."/>
  <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>