Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

## : Example of Research Study - TTL Representation

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    @prefix fhir: <http://hl7.org/fhir/> .
    @prefix owl: <http://www.w3.org/2002/07/owl#> .
    @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
    @prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

    # - resource -------------------------------------------------------------------

     a fhir:ResearchStudy ;
      fhir:nodeRole fhir:treeRoot ;
      fhir:id [ fhir:v "ResearchStudyExample-sIRB"] ; #
      fhir:meta [
    fhir:versionId [ fhir:v "2" ] ;
    fhir:lastUpdated [ fhir:v "2021-07-28T19:08:33.805+00:00"^^xsd:dateTime ]
      ] ; #
      fhir:text [
    fhir:status [ fhir:v "generated" ] ;
    fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"ResearchStudyExample-sIRB\"> </a></p><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\">Resource ResearchStudy &quot;ResearchStudyExample-sIRB&quot; Version &quot;2&quot; Updated &quot;2021-07-28 19:08:33+0000&quot; </p></div><p><b>identifier</b>: The Questionnaire Response ID for the associated Initiate a Study FHIR Questionnaire Response: initiate-study-populate-exampleQR (use: USUAL), IRB Study Protocol Number assigned by the research study management database of the lead institution: PRO098765 (use: USUAL)</p><p><b>title</b>: A clinical study of the efficacy of Drug A for arthritis</p><p><b>protocol</b>: <a name=\"plandefinition-initiate-study-populate-exampleQR\"> </a></p><blockquote><p/><p><a name=\"plandefinition-initiate-study-populate-exampleQR\"> </a></p><p><b>identifier</b>: id: PRO098765 (use: USUAL)</p><p><b>name</b>: PlanDefInitiateStudyPopulateExampleQR</p><p><b>status</b>: draft</p></blockquote><p><b>status</b>: in-review</p><p><b>category</b>: Interventional Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C98388)</span></p><p><b>keyword</b>: Gov-123456 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (www.protocols.examplenationalgovernmentfunder.org#Gov-123456)</span></p><p><b>principalInvestigator</b>: <a name=\"practitioner-initiate-study-populate-exampleQR\"> </a></p><blockquote><p/><p><a name=\"practitioner-initiate-study-populate-exampleQR\"> </a></p><p><b>name</b>: Jane Doe, MD(OFFICIAL)</p></blockquote><hr/><blockquote><p><b>Generated Narrative: PlanDefinition #plandefinition-initiate-study-populate-exampleQR</b><a name=\"plandefinition-initiate-study-populate-exampleQR\"> </a></p><p><b>identifier</b>: id: PRO098765 (use: USUAL)</p><p><b>name</b>: PlanDefInitiateStudyPopulateExampleQR</p><p><b>status</b>: draft</p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #practitioner-initiate-study-populate-exampleQR</b><a name=\"practitioner-initiate-study-populate-exampleQR\"> </a></p><p><b>name</b>: Jane Doe, MD(OFFICIAL)</p></blockquote></div>"
      ] ; #
      fhir:contained ( [
    a fhir:PlanDefinition ;
    fhir:id [ fhir:v "plandefinition-initiate-study-populate-exampleQR" ] ;
        ( fhir:identifier [
    fhir:use [ fhir:v "usual" ] ;
    fhir:system [ fhir:v "https://www.examplestudymanagementdb.org"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "PRO098765" ]     ] ) ;
    fhir:name [ fhir:v "PlanDefInitiateStudyPopulateExampleQR" ] ;
    fhir:status [ fhir:v "draft" ]
      ] [
    a fhir:Practitioner ;
    fhir:id [ fhir:v "practitioner-initiate-study-populate-exampleQR" ] ;
        ( fhir:name [
    fhir:use [ fhir:v "official" ] ;
    fhir:text [ fhir:v "Jane Doe, MD" ] ;
    fhir:family [ fhir:v "Doe" ] ;
          ( fhir:given [ fhir:v "Jane" ] ) ;
          ( fhir:suffix [ fhir:v "MD" ] )     ] )
      ] ) ; #
      fhir:identifier ( [
    fhir:use [ fhir:v "usual" ] ;
    fhir:type [
    fhir:text [ fhir:v "The Questionnaire Response ID for the associated Initiate a Study FHIR Questionnaire Response" ]     ] ;
    fhir:system [ fhir:v "https://hl7.org/fhir/us/sirb/QuestionnaireResponse"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "initiate-study-populate-exampleQR" ]
      ] [
    fhir:use [ fhir:v "usual" ] ;
    fhir:type [
    fhir:text [ fhir:v "IRB Study Protocol Number assigned by the research study management database of the lead institution" ]     ] ;
    fhir:value [ fhir:v "PRO098765" ] ;
    fhir:assigner [
    fhir:display [ fhir:v "Sample University Medical Center" ]     ]
      ] ) ; #
      fhir:title [ fhir:v "A clinical study of the efficacy of Drug A for arthritis"] ; #
      fhir:protocol ( [
    fhir:reference [ fhir:v "#plandefinition-initiate-study-populate-exampleQR" ]
      ] ) ; #
      fhir:status [ fhir:v "in-review"] ; #
      fhir:category ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://ncimeta.nci.nih.gov"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C98388" ] ;
    fhir:display [ fhir:v "Interventional Study" ]     ] )
      ] ) ; #
      fhir:keyword ( [
        ( fhir:coding [
    fhir:system [ fhir:v "https://www.protocols.examplenationalgovernmentfunder.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "Gov-123456" ]     ] ) ;
    fhir:text [ fhir:v "Gov-123456" ]
      ] ) ; #
      fhir:principalInvestigator [
    fhir:reference [ fhir:v "#practitioner-initiate-study-populate-exampleQR" ]
      ] . #