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 - XML Representation

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<ResearchStudy xmlns="http://hl7.org/fhir">
  <id value="ResearchStudy2858"/>
  <meta>
    <versionId value="2"/>
    <lastUpdated value="2021-07-28T19:08:33.805+00:00"/>
    <source value="#zj1czTsuUAVvoEBr"/>
  </meta>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <contained>
    <PlanDefinition>
      <id value="plan_definition-2857"/>
      <identifier>
        <use value="usual"/>
        <system value="https://www.examplestudymanagementdb.org"/>
        <value value="SUMC-1234567"/>
      </identifier>
      <name value="PlanDef2857"/>
      <status value="draft"/>
    </PlanDefinition>
  </contained>
  <contained>
    <Practitioner>
      <id value="practitioner-2857"/>
      <name>
        <use value="official"/>
        <text value="John Doe, IV, MD"/>
        <family value="Doe"/>
        <given value="John"/>
        <suffix value="IV"/>
        <suffix value="MD"/>
      </name>
    </Practitioner>
  </contained>
  <identifier>
    <use value="usual"/>
    <type>
      <text
            value="The Questionnaire Response ID for the associated Initiate a Study FHIR Questionnaire Response"/>
    </type>
    <system
            value="https://www.example-fhir-server.com/hapi-fhir-jpaserver/fhir/QuestionnaireResponse"/>
    <value value="QRID-2857"/>
  </identifier>
  <identifier>
    <use value="usual"/>
    <type>
      <text
            value="IRB Study Protocol Number assigned by the sIRB&#39;s external research study database"/>
    </type>
    <value value="SUMC-1234567"/>
    <assigner>
      <display value="Sample University Medical Center(SUMC)"/>
    </assigner>
  </identifier>
  <title
         value="Double blind, placebo-controlled trial of a new class of arthritis medication"/>
  <protocol>
    <reference value="#plan_definition-2857"/>
  </protocol>
  <status value="in-review"/>
  <category>
    <coding>
      <system value="http://ncimeta.nci.nih.gov"/>
      <code value="C98388"/>
      <display value="Interventional Study"/>
    </coding>
  </category>
  <keyword>
    <coding>
      <system value="https://www.examplestudymanagementdb.org"/>
      <code value="NIH-2021-123456"/>
    </coding>
    <text value="NIH-2021-123456"/>
  </keyword>
  <principalInvestigator>
    <reference value="#practitioner-2857"/>
  </principalInvestigator>
</ResearchStudy>