Single Institutional Review Board (sIRB) Implementation Guide
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This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, 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" ]
  ] . #