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 - 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"
      }
    }