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 - XML Representation

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    <ResearchStudy xmlns="http://hl7.org/fhir">
      <id value="ResearchStudyExample-sIRB"/>
      <meta>
        <versionId value="2"/>
        <lastUpdated value="2021-07-28T19:08:33.805+00:00"/>
      </meta>
      <text>
        <status value="generated"/>
        <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: initiate-study-populate-exampleQR (use: USUAL), IRB Study Protocol Number assigned by the research study management database of the lead institution: PRO098765 (use: USUAL)</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: PRO098765 (use: USUAL)</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: PRO098765 (use: USUAL)</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>
      </text>
      <contained>
        <PlanDefinition>
          <id value="plandefinition-initiate-study-populate-exampleQR"/>
          <identifier>
            <use value="usual"/>
            <system value="https://www.examplestudymanagementdb.org"/>
            <value value="PRO098765"/>
          </identifier>
          <name value="PlanDefInitiateStudyPopulateExampleQR"/>
          <status value="draft"/>
        </PlanDefinition>
      </contained>
      <contained>
        <Practitioner>
          <id value="practitioner-initiate-study-populate-exampleQR"/>
          <name>
            <use value="official"/>
            <text value="Jane Doe, MD"/>
            <family value="Doe"/>
            <given value="Jane"/>
            <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://hl7.org/fhir/us/sirb/QuestionnaireResponse"/>
        <value value="initiate-study-populate-exampleQR"/>
      </identifier>
      <identifier>
        <use value="usual"/>
        <type>
          <text
                value="IRB Study Protocol Number assigned by the research study management database of the lead institution"/>
        </type>
        <value value="PRO098765"/>
        <assigner>
          <display value="Sample University Medical Center"/>
        </assigner>
      </identifier>
      <title value="A clinical study of the efficacy of Drug A for arthritis"/>
      <protocol>
        <reference value="#plandefinition-initiate-study-populate-exampleQR"/>
      </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.protocols.examplenationalgovernmentfunder.org"/>
          <code value="Gov-123456"/>
        </coding>
        <text value="Gov-123456"/>
      </keyword>
      <principalInvestigator>
        <reference value="#practitioner-initiate-study-populate-exampleQR"/>
      </principalInvestigator>
    </ResearchStudy>