Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use United States of America flag

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v1.0.0: STU 1) based on FHIR R4. This is the current published version. 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="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>