Definition for Code SystemResearchStudyPartyRole

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


<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-party-role"/> 
  <meta> 
    
    

    <lastUpdated value="2025-11-27T16:48:47+00:00"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      This code system 

      <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>       </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> 
          
          
        
        
          study-director
            
          
          
          

          <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> 
  </text> 
  <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-ballot3"/> 
  <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."/> 
  <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

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