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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
<?xml version="1.0" encoding="UTF-8"?> <CodeSystem xmlns="http://hl7.org/fhir"> <id value="research-study-party-role"/> <meta> <lastUpdated value="2025-03-18T13:49:06+00:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </meta> <text> <status value="generated"/> <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> <a name="research-study-party-role-en-US"> </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> </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="trial-use"/> </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-ballot2"/> <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> </CodeSystem>
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-ballot2 generated on Tue, Mar 18, 2025 13:55+0000.
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