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" : "INITIATE-QR",
"meta" : {
"versionId" : "2",
"lastUpdated" : "2021-07-25T19:47:30.979+00:00",
"source" : "#jPrXQW4xZAW3qV7B"
},
"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-initiate-study-questionnaire\">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 5:52:41 AM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in1</p><p><b>text</b>: Research Study Details</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in1.2</p><p><b>text</b>: Study Title (Short)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in1.3</p><p><b>text</b>: IRB Protocol Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in1.4</p><p><b>text</b>: Study Type</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5</p><p><b>text</b>: Other Organization(s) Involved</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.1</p><p><b>text</b>: Relationship Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.2</p><p><b>text</b>: Organization Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.3</p><p><b>text</b>: Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.4</p><p><b>text</b>: Sponsor or Funding Source Protocol Number, if applicable</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5</p><p><b>text</b>: Other Organization(s) Involved</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.1</p><p><b>text</b>: Relationship Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.2</p><p><b>text</b>: Organization Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.3</p><p><b>text</b>: Phone</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5</p><p><b>text</b>: Other Organization(s) Involved</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.1</p><p><b>text</b>: Relationship Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.2</p><p><b>text</b>: Organization Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.3</p><p><b>text</b>: Phone</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6</p><p><b>text</b>: sIRB (Reviewing Institution)</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.1</p><p><b>text</b>: sIRB (Reviewing Institution) Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.3</p><p><b>text</b>: Institution Street Address</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.4</p><p><b>text</b>: Institution City</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.5</p><p><b>text</b>: Institution State</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.6</p><p><b>text</b>: Institution Zip Code</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.7</p><p><b>text</b>: Institution Country</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.8</p><p><b>text</b>: Is a Federal Wide Assurance (FWA) Number assigned?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.9</p><p><b>text</b>: Federal Wide Assurance Number (if assigned)</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7</p><p><b>text</b>: Overall Principal Investigator for the Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.1</p><p><b>text</b>: Overall Principal Investigator First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.2</p><p><b>text</b>: Overall Principal Investigator Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.3</p><p><b>text</b>: Overall Principal Investigator Suffix</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.4</p><p><b>text</b>: Academic and Professional Degrees associated with the Overall Principal Investigator</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.5</p><p><b>text</b>: Overall Principal Investigator Institution Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.6</p><p><b>text</b>: Department Name or Division</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.7</p><p><b>text</b>: Street Address</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.8</p><p><b>text</b>: City</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.9</p><p><b>text</b>: State</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.10</p><p><b>text</b>: Zip Code</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.11</p><p><b>text</b>: Country</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.12</p><p><b>text</b>: Overall Principal Investigator Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.13</p><p><b>text</b>: Overall Principal Investigator Email Address</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in8</p><p><b>text</b>: Confirmed or Potential Relying Site(s)</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in8.1</p><p><b>text</b>: Confirmed or Potential Relying Site Overview</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in8.3</p><p><b>text</b>: Site Principal Investigator at Relying Site</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in8</p><p><b>text</b>: Confirmed or Potential Relying Site(s)</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in8.1</p><p><b>text</b>: Confirmed or Potential Relying Site Overview</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in8.3</p><p><b>text</b>: Site Principal Investigator at Relying Site</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in9</p><p><b>text</b>: Questionnaire Version Details</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in9.1</p><p><b>text</b>: Questionnaire Version</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in9.2</p><p><b>text</b>: Questionnaire Version Date</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN00</p><p><b>text</b>: Administrative Use Only (will be hidden in the future)</p><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN01</p><p><b>text</b>: Link ID prefix</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN02</p><p><b>text</b>: Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN03</p><p><b>text</b>: ID of the Research Study FHIR Resource associated with the study Questionnaire Responses</p></blockquote></blockquote></div>"
},
"questionnaire" : "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire",
"status" : "completed",
"authored" : "2021-07-23T05:52:41.328Z",
"item" : [
{
"linkId" : "in1",
"text" : "Research Study Details",
"item" : [
{
"linkId" : "in1.1",
"text" : "Study Title",
"answer" : [
{
"valueString" : "Double blind, placebo-controlled trial of a new class of arthritis medication"
}
]
},
{
"linkId" : "in1.2",
"text" : "Study Title (Short)",
"answer" : [
{
"valueString" : "Testing a new arthritis medication"
}
]
},
{
"linkId" : "in1.3",
"text" : "IRB Protocol Number",
"answer" : [
{
"valueString" : "SUMC-1234567"
}
]
},
{
"linkId" : "in1.4",
"text" : "Study Type",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "INT",
"display" : "Interventional"
}
}
]
}
]
},
{
"linkId" : "in5",
"text" : "Other Organization(s) Involved",
"item" : [
{
"linkId" : "in5.1",
"text" : "Relationship Type",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "SFS",
"display" : "Sponsor or Funding Source"
}
}
]
},
{
"linkId" : "in5.2",
"text" : "Organization Name",
"answer" : [
{
"valueString" : "NIH"
}
]
},
{
"linkId" : "in5.3",
"text" : "Phone",
"answer" : [
{
"valueString" : "800-123-1234"
}
]
},
{
"linkId" : "in5.4",
"text" : "Sponsor or Funding Source Protocol Number, if applicable",
"answer" : [
{
"valueString" : "NIH-2021-123456"
}
]
}
]
},
{
"linkId" : "in5",
"text" : "Other Organization(s) Involved",
"item" : [
{
"linkId" : "in5.1",
"text" : "Relationship Type",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "SFS",
"display" : "Sponsor or Funding Source"
}
}
]
},
{
"linkId" : "in5.2",
"text" : "Organization Name",
"answer" : [
{
"valueString" : "Organization of Arthritis Patients Foundatio"
}
]
},
{
"linkId" : "in5.3",
"text" : "Phone",
"answer" : [
{
"valueString" : "123-123-1234"
}
]
}
]
},
{
"linkId" : "in5",
"text" : "Other Organization(s) Involved",
"item" : [
{
"linkId" : "in5.1",
"text" : "Relationship Type",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "CRO",
"display" : "Contract Research Organization (CRO)"
}
}
]
},
{
"linkId" : "in5.2",
"text" : "Organization Name",
"answer" : [
{
"valueString" : "Sample CRO, Inc."
}
]
},
{
"linkId" : "in5.3",
"text" : "Phone",
"answer" : [
{
"valueString" : "234-123-1234"
}
]
}
]
},
{
"linkId" : "in6",
"text" : "sIRB (Reviewing Institution)",
"item" : [
{
"linkId" : "in6.1",
"text" : "sIRB (Reviewing Institution) Name",
"answer" : [
{
"valueString" : "Sample University Medical Center"
}
]
},
{
"linkId" : "in6.3",
"text" : "Institution Street Address",
"answer" : [
{
"valueString" : "100 Sample University Drive"
}
]
},
{
"linkId" : "in6.4",
"text" : "Institution City",
"answer" : [
{
"valueString" : "Sample City"
}
]
},
{
"linkId" : "in6.5",
"text" : "Institution State",
"answer" : [
{
"valueString" : "NC"
}
]
},
{
"linkId" : "in6.6",
"text" : "Institution Zip Code",
"answer" : [
{
"valueString" : "12345"
}
]
},
{
"linkId" : "in6.7",
"text" : "Institution Country",
"answer" : [
{
"valueString" : "United States"
}
]
},
{
"linkId" : "in6.8",
"text" : "Is a Federal Wide Assurance (FWA) Number assigned?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "in6.9",
"text" : "Federal Wide Assurance Number (if assigned)",
"answer" : [
{
"valueInteger" : 56789
}
]
}
]
},
{
"linkId" : "in7",
"text" : "Overall Principal Investigator for the Study",
"item" : [
{
"linkId" : "in7.1",
"text" : "Overall Principal Investigator First Name",
"answer" : [
{
"valueString" : "John"
}
]
},
{
"linkId" : "in7.2",
"text" : "Overall Principal Investigator Last Name",
"answer" : [
{
"valueString" : "Doe"
}
]
},
{
"linkId" : "in7.3",
"text" : "Overall Principal Investigator Suffix",
"answer" : [
{
"valueString" : "IV"
}
]
},
{
"linkId" : "in7.4",
"text" : "Academic and Professional Degrees associated with the Overall Principal Investigator",
"answer" : [
{
"valueString" : "MD"
}
]
},
{
"linkId" : "in7.5",
"text" : "Overall Principal Investigator Institution Name",
"answer" : [
{
"valueString" : "Sample University Medical Center"
}
]
},
{
"linkId" : "in7.6",
"text" : "Department Name or Division",
"answer" : [
{
"valueString" : "Orthopedics"
}
]
},
{
"linkId" : "in7.7",
"text" : "Street Address",
"answer" : [
{
"valueString" : "105 Sample University Ct."
}
]
},
{
"linkId" : "in7.8",
"text" : "City",
"answer" : [
{
"valueString" : "Sample City"
}
]
},
{
"linkId" : "in7.9",
"text" : "State",
"answer" : [
{
"valueString" : "NC"
}
]
},
{
"linkId" : "in7.10",
"text" : "Zip Code",
"answer" : [
{
"valueString" : "12345"
}
]
},
{
"linkId" : "in7.11",
"text" : "Country",
"answer" : [
{
"valueString" : "United States"
}
]
},
{
"linkId" : "in7.12",
"text" : "Overall Principal Investigator Phone",
"answer" : [
{
"valueString" : "567-123-1234"
}
]
},
{
"linkId" : "in7.13",
"text" : "Overall Principal Investigator Email Address",
"answer" : [
{
"valueString" : "drjohndoe@sampleuniversity.edu"
}
]
}
]
},
{
"linkId" : "in8",
"text" : "Confirmed or Potential Relying Site(s)",
"item" : [
{
"linkId" : "in8.1",
"text" : "Confirmed or Potential Relying Site Overview",
"item" : [
{
"linkId" : "in8.1.1",
"text" : "Relying Institution Name",
"answer" : [
{
"valueString" : "Test Example University"
}
]
},
{
"linkId" : "in8.1.3",
"text" : "Relying Institution Phone",
"answer" : [
{
"valueString" : "6781233456"
}
]
},
{
"linkId" : "in8.1.4",
"text" : "Is a Federal Wide Assurance (FWA) Number assigned?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "in8.1.5",
"text" : "Federal Wide Assurance Number (if assigned)",
"answer" : [
{
"valueInteger" : 34567
}
]
},
{
"linkId" : "in8.1.6",
"text" : "Reliance Status",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "APPROVED",
"display" : "Approved for reliance"
}
}
]
},
{
"linkId" : "in8.1.7",
"text" : "Relying Site Address",
"item" : [
{
"linkId" : "in8.1.7.1",
"text" : "Street Address",
"answer" : [
{
"valueString" : "100 Test Example Circle"
}
]
},
{
"linkId" : "in8.1.7.2",
"text" : "City",
"answer" : [
{
"valueString" : "Example"
}
]
},
{
"linkId" : "in8.1.7.3",
"text" : "State",
"answer" : [
{
"valueString" : "MA"
}
]
},
{
"linkId" : "in8.1.7.4",
"text" : "Zip Code",
"answer" : [
{
"valueString" : "67890"
}
]
},
{
"linkId" : "in8.1.7.5",
"text" : "Country",
"answer" : [
{
"valueString" : "United States"
}
]
}
]
}
]
},
{
"linkId" : "in8.3",
"text" : "Site Principal Investigator at Relying Site",
"item" : [
{
"linkId" : "in8.3.1",
"text" : "Relying Site Principal Investigator First Name",
"answer" : [
{
"valueString" : "Xi"
}
]
},
{
"linkId" : "in8.3.2",
"text" : "Relying Site Principal Investigator Last Name",
"answer" : [
{
"valueString" : "Lee"
}
]
},
{
"linkId" : "in8.3.4",
"text" : "Academic and Professional Degrees associated with the Relying Site Principal Investigator",
"answer" : [
{
"valueString" : "MD, PhD"
}
]
},
{
"linkId" : "in8.3.5",
"text" : "Phone",
"answer" : [
{
"valueString" : "6781233456"
}
]
},
{
"linkId" : "in8.3.6",
"text" : "Email address",
"answer" : [
{
"valueString" : "xi.lee@teu.med.ed"
}
]
},
{
"linkId" : "in8.3.7",
"text" : "Address of Relying Site Principal Investigator",
"item" : [
{
"linkId" : "in8.3.7.1",
"text" : "Street Address",
"answer" : [
{
"valueString" : "200 Test Example Circle"
}
]
},
{
"linkId" : "in8.3.7.2",
"text" : "City",
"answer" : [
{
"valueString" : "Example"
}
]
},
{
"linkId" : "in8.3.7.3",
"text" : "State",
"answer" : [
{
"valueString" : "MA"
}
]
},
{
"linkId" : "in8.3.7.4",
"text" : "Zip Code",
"answer" : [
{
"valueString" : "67890"
}
]
},
{
"linkId" : "in8.3.7.5",
"text" : "Country",
"answer" : [
{
"valueString" : "United States"
}
]
}
]
}
]
}
]
},
{
"linkId" : "in8",
"text" : "Confirmed or Potential Relying Site(s)",
"item" : [
{
"linkId" : "in8.1",
"text" : "Confirmed or Potential Relying Site Overview",
"item" : [
{
"linkId" : "in8.1.1",
"text" : "Relying Institution Name",
"answer" : [
{
"valueString" : "Central Campus Test University"
}
]
},
{
"linkId" : "in8.1.3",
"text" : "Relying Institution Phone",
"answer" : [
{
"valueString" : "8901231234"
}
]
},
{
"linkId" : "in8.1.4",
"text" : "Is a Federal Wide Assurance (FWA) Number assigned?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "NI",
"display" : "No Information"
}
}
]
},
{
"linkId" : "in8.1.6",
"text" : "Reliance Status",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "POSSIBLE",
"display" : "Potential/possible"
}
}
]
},
{
"linkId" : "in8.1.7",
"text" : "Relying Site Address",
"item" : [
{
"linkId" : "in8.1.7.1",
"text" : "Street Address",
"answer" : [
{
"valueString" : "100 Central St."
}
]
},
{
"linkId" : "in8.1.7.2",
"text" : "City",
"answer" : [
{
"valueString" : "Central"
}
]
},
{
"linkId" : "in8.1.7.3",
"text" : "State",
"answer" : [
{
"valueString" : "MI"
}
]
},
{
"linkId" : "in8.1.7.4",
"text" : "Zip Code",
"answer" : [
{
"valueString" : "23456"
}
]
},
{
"linkId" : "in8.1.7.5",
"text" : "Country",
"answer" : [
{
"valueString" : "United States"
}
]
}
]
}
]
},
{
"linkId" : "in8.3",
"text" : "Site Principal Investigator at Relying Site",
"item" : [
{
"linkId" : "in8.3.1",
"text" : "Relying Site Principal Investigator First Name",
"answer" : [
{
"valueString" : "Maria"
}
]
},
{
"linkId" : "in8.3.2",
"text" : "Relying Site Principal Investigator Last Name",
"answer" : [
{
"valueString" : "Smith"
}
]
},
{
"linkId" : "in8.3.4",
"text" : "Academic and Professional Degrees associated with the Relying Site Principal Investigator",
"answer" : [
{
"valueString" : "PhD"
}
]
},
{
"linkId" : "in8.3.5",
"text" : "Phone",
"answer" : [
{
"valueString" : "8901231234"
}
]
},
{
"linkId" : "in8.3.6",
"text" : "Email address",
"answer" : [
{
"valueString" : "maria.smith@CCTU.med.edu"
}
]
},
{
"linkId" : "in8.3.7",
"text" : "Address of Relying Site Principal Investigator",
"item" : [
{
"linkId" : "in8.3.7.1",
"text" : "Street Address",
"answer" : [
{
"valueString" : "200 Central St."
}
]
},
{
"linkId" : "in8.3.7.2",
"text" : "City",
"answer" : [
{
"valueString" : "Central"
}
]
},
{
"linkId" : "in8.3.7.3",
"text" : "State",
"answer" : [
{
"valueString" : "MI"
}
]
},
{
"linkId" : "in8.3.7.4",
"text" : "Zip Code",
"answer" : [
{
"valueString" : "23456"
}
]
},
{
"linkId" : "in8.3.7.5",
"text" : "Country",
"answer" : [
{
"valueString" : "United States"
}
]
}
]
}
]
}
]
},
{
"linkId" : "in9",
"text" : "Questionnaire Version Details",
"item" : [
{
"linkId" : "in9.1",
"text" : "Questionnaire Version",
"answer" : [
{
"valueString" : "1"
}
]
},
{
"linkId" : "in9.2",
"text" : "Questionnaire Version Date",
"answer" : [
{
"valueDate" : "2021-06-01"
}
]
}
]
},
{
"linkId" : "ADMIN00",
"text" : "Administrative Use Only (will be hidden in the future)",
"item" : [
{
"linkId" : "ADMIN01",
"text" : "Link ID prefix",
"answer" : [
{
"valueString" : "in"
}
]
},
{
"linkId" : "ADMIN02",
"text" : "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any",
"answer" : [
{
"valueString" : "temporarily unavailable"
}
]
},
{
"linkId" : "ADMIN03",
"text" : "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses",
"answer" : [
{
"valueString" : "temporarily unavailable"
}
]
}
]
}
]
}
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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