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 - JSON Representation

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{
  "resourceType" : "ResearchStudy",
  "id" : "ResearchStudy2858",
  "meta" : {
    "versionId" : "2",
    "lastUpdated" : "2021-07-28T19:08:33.805+00:00",
    "source" : "#zj1czTsuUAVvoEBr"
  },
  "text" : {
    "status" : "generated",
    "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>"
  },
  "contained" : [
    {
      "resourceType" : "PlanDefinition",
      "id" : "plan_definition-2857",
      "identifier" : [
        {
          "use" : "usual",
          "system" : "https://www.examplestudymanagementdb.org",
          "value" : "SUMC-1234567"
        }
      ],
      "name" : "PlanDef2857",
      "status" : "draft"
    },
    {
      "resourceType" : "Practitioner",
      "id" : "practitioner-2857",
      "name" : [
        {
          "use" : "official",
          "text" : "John Doe, IV, MD",
          "family" : "Doe",
          "given" : [
            "John"
          ],
          "suffix" : [
            "IV",
            "MD"
          ]
        }
      ]
    }
  ],
  "identifier" : [
    {
      "use" : "usual",
      "type" : {
        "text" : "The Questionnaire Response ID for the associated Initiate a Study FHIR Questionnaire Response"
      },
      "system" : "https://www.example-fhir-server.com/hapi-fhir-jpaserver/fhir/QuestionnaireResponse",
      "value" : "QRID-2857"
    },
    {
      "use" : "usual",
      "type" : {
        "text" : "IRB Study Protocol Number assigned by the sIRB's external research study database"
      },
      "value" : "SUMC-1234567",
      "assigner" : {
        "display" : "Sample University Medical Center(SUMC)"
      }
    }
  ],
  "title" : "Double blind, placebo-controlled trial of a new class of arthritis medication",
  "protocol" : [
    {
      "reference" : "#plan_definition-2857"
    }
  ],
  "status" : "in-review",
  "category" : [
    {
      "coding" : [
        {
          "system" : "http://ncimeta.nci.nih.gov",
          "code" : "C98388",
          "display" : "Interventional Study"
        }
      ]
    }
  ],
  "keyword" : [
    {
      "coding" : [
        {
          "system" : "https://www.examplestudymanagementdb.org",
          "code" : "NIH-2021-123456"
        }
      ],
      "text" : "NIH-2021-123456"
    }
  ],
  "principalInvestigator" : {
    "reference" : "#practitioner-2857"
  }
}