Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . 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:Resource.id [ fhir:value "ResearchStudy2858"];
  fhir:Resource.meta [
     fhir:Meta.versionId [ fhir:value "2" ];
     fhir:Meta.lastUpdated [ fhir:value "2021-07-28T19:08:33.805+00:00"^^xsd:dateTime ];
     fhir:Meta.source [ fhir:value "#zj1czTsuUAVvoEBr" ]
  ];
  fhir:DomainResource.text [
     fhir:Narrative.status [ fhir:value "generated" ];
     fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative</b></p><p><b>identifier</b>: The Questionnaire Response ID for the associated Initiate a Study FHIR Questionnaire Response: QRID-2857 (USUAL), IRB Study Protocol Number assigned by the sIRB's external research study database: SUMC-1234567 (USUAL)</p><p><b>title</b>: Double blind, placebo-controlled trial of a new class of arthritis medication</p><p><b>protocol</b>: <a name=\"plan_definition-2857\"> </a></p><blockquote><p><b>identifier</b>: id: SUMC-1234567 (USUAL)</p><p><b>name</b>: PlanDef2857</p><p><b>status</b>: draft</p></blockquote><p><b>status</b>: in-review</p><p><b>category</b>: <span title=\"Codes: {http://ncimeta.nci.nih.gov C98388}\">Interventional Study</span></p><p><b>keyword</b>: <span title=\"Codes: {https://www.examplestudymanagementdb.org NIH-2021-123456}\">NIH-2021-123456</span></p><p><b>principalInvestigator</b>: <a name=\"practitioner-2857\"> </a></p><blockquote><p><b>name</b>: John Doe, IV, MD(OFFICIAL)</p></blockquote></div>"
  ];
  fhir:DomainResource.contained [
     a fhir:PlanDefinition;
     fhir:index 0;
     fhir:Resource.id [ fhir:value "plan_definition-2857" ];
     fhir:PlanDefinition.identifier [
       fhir:index 0;
       fhir:Identifier.use [ fhir:value "usual" ];
       fhir:Identifier.system [ fhir:value "https://www.examplestudymanagementdb.org" ];
       fhir:Identifier.value [ fhir:value "SUMC-1234567" ]     ];
     fhir:PlanDefinition.name [ fhir:value "PlanDef2857" ];
     fhir:PlanDefinition.status [ fhir:value "draft" ]
  ], [
     a fhir:Practitioner;
     fhir:index 1;
     fhir:Resource.id [ fhir:value "practitioner-2857" ];
     fhir:Practitioner.name [
       fhir:index 0;
       fhir:HumanName.use [ fhir:value "official" ];
       fhir:HumanName.text [ fhir:value "John Doe, IV, MD" ];
       fhir:HumanName.family [ fhir:value "Doe" ];
       fhir:HumanName.given [
         fhir:value "John";
         fhir:index 0       ];
       fhir:HumanName.suffix [
         fhir:value "IV";
         fhir:index 0       ], [
         fhir:value "MD";
         fhir:index 1       ]     ]
  ];
  fhir:ResearchStudy.identifier [
     fhir:index 0;
     fhir:Identifier.use [ fhir:value "usual" ];
     fhir:Identifier.type [
       fhir:CodeableConcept.text [ fhir:value "The Questionnaire Response ID for the associated Initiate a Study FHIR Questionnaire Response" ]     ];
     fhir:Identifier.system [ fhir:value "https://www.example-fhir-server.com/hapi-fhir-jpaserver/fhir/QuestionnaireResponse" ];
     fhir:Identifier.value [ fhir:value "QRID-2857" ]
  ], [
     fhir:index 1;
     fhir:Identifier.use [ fhir:value "usual" ];
     fhir:Identifier.type [
       fhir:CodeableConcept.text [ fhir:value "IRB Study Protocol Number assigned by the sIRB's external research study database" ]     ];
     fhir:Identifier.value [ fhir:value "SUMC-1234567" ];
     fhir:Identifier.assigner [
       fhir:Reference.display [ fhir:value "Sample University Medical Center(SUMC)" ]     ]
  ];
  fhir:ResearchStudy.title [ fhir:value "Double blind, placebo-controlled trial of a new class of arthritis medication"];
  fhir:ResearchStudy.protocol [
     fhir:index 0;
     fhir:Reference.reference [ fhir:value "#plan_definition-2857" ]
  ];
  fhir:ResearchStudy.status [ fhir:value "in-review"];
  fhir:ResearchStudy.category [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
       fhir:Coding.code [ fhir:value "C98388" ];
       fhir:Coding.display [ fhir:value "Interventional Study" ]     ]
  ];
  fhir:ResearchStudy.keyword [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "https://www.examplestudymanagementdb.org" ];
       fhir:Coding.code [ fhir:value "NIH-2021-123456" ]     ];
     fhir:CodeableConcept.text [ fhir:value "NIH-2021-123456" ]
  ];
  fhir:ResearchStudy.principalInvestigator [
     fhir:Reference.reference [ fhir:value "#practitioner-2857" ]
  ].

# - ontology header ------------------------------------------------------------

 a owl:Ontology;
  owl:imports fhir:fhir.ttl.