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 
{
"resourceType" : "QuestionnaireResponse",
"id" : "DETERMINATION-QR",
"meta" : {
"versionId" : "2",
"lastUpdated" : "2021-07-27T15:48:47.066+00:00",
"source" : "#HVWOJN3tCJYGmPWD"
},
"text" : {
"status" : "generated",
"div" : "<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>"
},
"questionnaire" : "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire",
"status" : "completed",
"authored" : "2021-07-23T15:23:55.475Z",
"item" : [
{
"linkId" : "dl1",
"text" : "Research Study",
"item" : [
{
"linkId" : "dl1.1",
"text" : "Study Title",
"answer" : [
{
"valueString" : "Testing a new arthritis medication"
}
]
},
{
"linkId" : "dl1.2",
"text" : "IRB Protocol Number",
"answer" : [
{
"valueString" : "SUMC-1234567"
}
]
}
]
},
{
"linkId" : "dl2",
"text" : "Reliance Determination",
"item" : [
{
"linkId" : "dl2.1",
"text" : "sIRB (Reviewing Institution)",
"item" : [
{
"linkId" : "dl2.1.1",
"text" : "Institution",
"item" : [
{
"linkId" : "dl2.1.1.1",
"text" : "sIRB (Reviewing Institution) Name",
"answer" : [
{
"valueString" : "Sample University Medical Center"
}
]
},
{
"linkId" : "dl2.1.1.2",
"text" : "Federal Wide Assurance (FWA):",
"answer" : [
{
"valueInteger" : 56789
}
]
}
]
},
{
"linkId" : "dl2.1.2",
"text" : "Point of Contact",
"item" : [
{
"linkId" : "dl2.1.2.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "John"
}
]
},
{
"linkId" : "dl2.1.2.2",
"text" : "Last Name",
"answer" : [
{
"valueString" : "Doe"
}
]
},
{
"linkId" : "dl2.1.2.4",
"text" : "Suffix",
"answer" : [
{
"valueString" : "IV"
}
]
},
{
"linkId" : "dl2.1.2.5",
"text" : "Professional Degree(s)",
"answer" : [
{
"valueString" : "MD"
}
]
},
{
"linkId" : "dl2.1.2.3",
"text" : "Email",
"answer" : [
{
"valueString" : "drjohndoe@sampleuniversity.edu"
}
]
}
]
},
{
"linkId" : "dl2.1.3",
"text" : "Overall Principal Investigator",
"item" : [
{
"linkId" : "dl2.1.3.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "John"
}
]
},
{
"linkId" : "dl2.1.3.2",
"text" : "Last Name",
"answer" : [
{
"valueString" : "Doe"
}
]
},
{
"linkId" : "dl2.1.3.4",
"text" : "Suffix",
"answer" : [
{
"valueString" : "IV"
}
]
},
{
"linkId" : "dl2.1.3.5",
"text" : "Degree(s)",
"answer" : [
{
"valueString" : "MD"
}
]
},
{
"linkId" : "dl2.1.3.3",
"text" : "Email",
"answer" : [
{
"valueString" : "drjohndoe@sampleuniversity.edu"
}
]
}
]
}
]
},
{
"linkId" : "dl2.2",
"text" : "Determination Decision",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "AR",
"display" : "Accepts Review"
}
}
]
},
{
"linkId" : "dl2.3",
"text" : "Relying IRB",
"item" : [
{
"linkId" : "dl2.3.1",
"text" : "Institution",
"item" : [
{
"linkId" : "dl2.3.1.1",
"text" : "Name",
"answer" : [
{
"valueString" : "Test Example University"
}
]
},
{
"linkId" : "dl2.3.1.2",
"text" : "Federal Wide Assurance (FWA)",
"answer" : [
{
"valueInteger" : 34567
}
]
}
]
},
{
"linkId" : "dl2.3.2",
"text" : "Site Principal Investigator",
"item" : [
{
"linkId" : "dl2.3.2.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "Xi"
}
]
},
{
"linkId" : "dl2.3.2.2",
"text" : "Last Name",
"answer" : [
{
"valueString" : "Lee"
}
]
},
{
"linkId" : "dl2.3.2.5",
"text" : "Professional Degree(s)",
"answer" : [
{
"valueString" : "MD, PhD"
}
]
},
{
"linkId" : "dl2.3.2.3",
"text" : "Email",
"answer" : [
{
"valueString" : "xi.lee@teu.med.edu"
}
]
}
]
}
]
}
]
},
{
"linkId" : "ADMIN00",
"text" : "Administrative Use Only",
"item" : [
{
"linkId" : "ADMIN01",
"text" : "Link ID prefix",
"answer" : [
{
"valueString" : "dl"
}
]
}
]
}
]
}
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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