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

• Narrative Content
• XML
• JSON
• TTL

: Example of Research Study - JSON Representation

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{
  "resourceType" : "ResearchStudy",
  "id" : "ResearchStudyExample-sIRB",
  "meta" : {
    "versionId" : "2",
    "lastUpdated" : "2021-07-28T19:08:33.805+00:00"
  },
  "text" : {
    "status" : "generated",
    "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:\u00a0initiate-study-populate-exampleQR\u00a0(use:\u00a0USUAL), IRB Study Protocol Number assigned by the research study management database of the lead institution:\u00a0PRO098765\u00a0(use:\u00a0USUAL)</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:\u00a0PRO098765\u00a0(use:\u00a0USUAL)</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:\u00a0PRO098765\u00a0(use:\u00a0USUAL)</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>"
  },
  "contained" : [
    {
      "resourceType" : "PlanDefinition",
      "id" : "plandefinition-initiate-study-populate-exampleQR",
      "identifier" : [
        {
          "use" : "usual",
          "system" : "https://www.examplestudymanagementdb.org",
          "value" : "PRO098765"
        }
      ],
      "name" : "PlanDefInitiateStudyPopulateExampleQR",
      "status" : "draft"
    },
    {
      "resourceType" : "Practitioner",
      "id" : "practitioner-initiate-study-populate-exampleQR",
      "name" : [
        {
          "use" : "official",
          "text" : "Jane Doe, MD",
          "family" : "Doe",
          "given" : [
            "Jane"
          ],
          "suffix" : [
            "MD"
          ]
        }
      ]
    }
  ],
  "identifier" : [
    {
      "use" : "usual",
      "type" : {
        "text" : "The Questionnaire Response ID for the associated Initiate a Study FHIR Questionnaire Response"
      },
      "system" : "https://hl7.org/fhir/us/sirb/QuestionnaireResponse",
      "value" : "initiate-study-populate-exampleQR"
    },
    {
      "use" : "usual",
      "type" : {
        "text" : "IRB Study Protocol Number assigned by the research study management database of the lead institution"
      },
      "value" : "PRO098765",
      "assigner" : {
        "display" : "Sample University Medical Center"
      }
    }
  ],
  "title" : "A clinical study of the efficacy of Drug A for arthritis",
  "protocol" : [
    {
      "reference" : "#plandefinition-initiate-study-populate-exampleQR"
    }
  ],
  "status" : "in-review",
  "category" : [
    {
      "coding" : [
        {
          "system" : "http://ncimeta.nci.nih.gov",
          "code" : "C98388",
          "display" : "Interventional Study"
        }
      ]
    }
  ],
  "keyword" : [
    {
      "coding" : [
        {
          "system" : "https://www.protocols.examplenationalgovernmentfunder.org",
          "code" : "Gov-123456"
        }
      ],
      "text" : "Gov-123456"
    }
  ],
  "principalInvestigator" : {
    "reference" : "#practitioner-initiate-study-populate-exampleQR"
  }
}