Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot
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 
<QuestionnaireResponse xmlns="http://hl7.org/fhir">
<id value="DETERMINATION-QR"/>
<meta>
<versionId value="2"/>
<lastUpdated value="2021-07-27T15:48:47.066+00:00"/>
<source value="#HVWOJN3tCJYGmPWD"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative</b></p><p><b>questionnaire</b>: <a href="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 3:23:55 PM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: dl1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: dl1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: dl1.2</p><p><b>text</b>: IRB Protocol Number</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: dl2</p><p><b>text</b>: Reliance Determination</p><blockquote><p><b>item</b></p><p><b>linkId</b>: dl2.1</p><p><b>text</b>: sIRB (Reviewing Institution)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: dl2.2</p><p><b>text</b>: Determination Decision</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: dl2.3</p><p><b>text</b>: Relying IRB</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN00</p><p><b>text</b>: Administrative Use Only</p><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN01</p><p><b>text</b>: Link ID prefix</p></blockquote></blockquote></div>
</text>
<questionnaire
value="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire"/>
<status value="completed"/>
<authored value="2021-07-23T15:23:55.475Z"/>
<item>
<linkId value="dl1"/>
<text value="Research Study"/>
<item>
<linkId value="dl1.1"/>
<text value="Study Title"/>
<answer>
<valueString value="Testing a new arthritis medication"/>
</answer>
</item>
<item>
<linkId value="dl1.2"/>
<text value="IRB Protocol Number"/>
<answer>
<valueString value="SUMC-1234567"/>
</answer>
</item>
</item>
<item>
<linkId value="dl2"/>
<text value="Reliance Determination"/>
<item>
<linkId value="dl2.1"/>
<text value="sIRB (Reviewing Institution)"/>
<item>
<linkId value="dl2.1.1"/>
<text value="Institution"/>
<item>
<linkId value="dl2.1.1.1"/>
<text value="sIRB (Reviewing Institution) Name"/>
<answer>
<valueString value="Sample University Medical Center"/>
</answer>
</item>
<item>
<linkId value="dl2.1.1.2"/>
<text value="Federal Wide Assurance (FWA):"/>
<answer>
<valueInteger value="56789"/>
</answer>
</item>
</item>
<item>
<linkId value="dl2.1.2"/>
<text value="Point of Contact"/>
<item>
<linkId value="dl2.1.2.1"/>
<text value="First Name"/>
<answer>
<valueString value="John"/>
</answer>
</item>
<item>
<linkId value="dl2.1.2.2"/>
<text value="Last Name"/>
<answer>
<valueString value="Doe"/>
</answer>
</item>
<item>
<linkId value="dl2.1.2.4"/>
<text value="Suffix"/>
<answer>
<valueString value="IV"/>
</answer>
</item>
<item>
<linkId value="dl2.1.2.5"/>
<text value="Professional Degree(s)"/>
<answer>
<valueString value="MD"/>
</answer>
</item>
<item>
<linkId value="dl2.1.2.3"/>
<text value="Email"/>
<answer>
<valueString value="drjohndoe@sampleuniversity.edu"/>
</answer>
</item>
</item>
<item>
<linkId value="dl2.1.3"/>
<text value="Overall Principal Investigator"/>
<item>
<linkId value="dl2.1.3.1"/>
<text value="First Name"/>
<answer>
<valueString value="John"/>
</answer>
</item>
<item>
<linkId value="dl2.1.3.2"/>
<text value="Last Name"/>
<answer>
<valueString value="Doe"/>
</answer>
</item>
<item>
<linkId value="dl2.1.3.4"/>
<text value="Suffix"/>
<answer>
<valueString value="IV"/>
</answer>
</item>
<item>
<linkId value="dl2.1.3.5"/>
<text value="Degree(s)"/>
<answer>
<valueString value="MD"/>
</answer>
</item>
<item>
<linkId value="dl2.1.3.3"/>
<text value="Email"/>
<answer>
<valueString value="drjohndoe@sampleuniversity.edu"/>
</answer>
</item>
</item>
</item>
<item>
<linkId value="dl2.2"/>
<text value="Determination Decision"/>
<answer>
<valueCoding>
<system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
<code value="AR"/>
<display value="Accepts Review"/>
</valueCoding>
</answer>
</item>
<item>
<linkId value="dl2.3"/>
<text value="Relying IRB"/>
<item>
<linkId value="dl2.3.1"/>
<text value="Institution"/>
<item>
<linkId value="dl2.3.1.1"/>
<text value="Name"/>
<answer>
<valueString value="Test Example University"/>
</answer>
</item>
<item>
<linkId value="dl2.3.1.2"/>
<text value="Federal Wide Assurance (FWA)"/>
<answer>
<valueInteger value="34567"/>
</answer>
</item>
</item>
<item>
<linkId value="dl2.3.2"/>
<text value="Site Principal Investigator"/>
<item>
<linkId value="dl2.3.2.1"/>
<text value="First Name"/>
<answer>
<valueString value="Xi"/>
</answer>
</item>
<item>
<linkId value="dl2.3.2.2"/>
<text value="Last Name"/>
<answer>
<valueString value="Lee"/>
</answer>
</item>
<item>
<linkId value="dl2.3.2.5"/>
<text value="Professional Degree(s)"/>
<answer>
<valueString value="MD, PhD"/>
</answer>
</item>
<item>
<linkId value="dl2.3.2.3"/>
<text value="Email"/>
<answer>
<valueString value="xi.lee@teu.med.edu"/>
</answer>
</item>
</item>
</item>
</item>
<item>
<linkId value="ADMIN00"/>
<text value="Administrative Use Only"/>
<item>
<linkId value="ADMIN01"/>
<text value="Link ID prefix"/>
<answer>
<valueString value="dl"/>
</answer>
</item>
</item>
</QuestionnaireResponse>
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.us.sirb#0.1.0 based on FHIR 4.0.1. Generated 2021-08-10
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