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" : "CONTINUING-REVIEW-QR",
"meta" : {
"versionId" : "2",
"lastUpdated" : "2021-07-28T19:30:37.109+00:00",
"source" : "#p17nsc0DW6GRC5C3"
},
"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-continuing-review-questionnaire\">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 27, 2021 3:22:08 PM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.2</p><p><b>text</b>: IRB Protocol Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.3</p><p><b>text</b>: Enrollment Status:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.4</p><p><b>text</b>: Intervention Status:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.5</p><p><b>text</b>: Study Status:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr1.6</p><p><b>text</b>: Funding Source(check all that are applicable):</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2</p><p><b>text</b>: Site Principal Investigator</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.1</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.4</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.6</p><p><b>text</b>: Degree(s)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.2</p><p><b>text</b>: Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr2.3</p><p><b>text</b>: Email:</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3a</p><p><b>text</b>: Report Type</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3a.1</p><p><b>text</b>: Is this an initial report?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3</p><p><b>text</b>: Accrual of Participants</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3.1</p><p><b>text</b>: Provide counts for the following:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr3.2</p><p><b>text</b>: Vulnerable Populations</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr4</p><p><b>text</b>: Study Report</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr4.5</p><p><b>text</b>: Since your last report (or since the study inception for an initial report):</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr5</p><p><b>text</b>: Adverse Events</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr5.1</p><p><b>text</b>: Have there been any internal or local adverse events in the research?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr5.3</p><p><b>text</b>: Have any protocol deviations or violations occurred in this study?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: cr6</p><p><b>text</b>: Conflict of Interest</p><blockquote><p><b>item</b></p><p><b>linkId</b>: cr6.1</p><p><b>text</b>: Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the 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><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, if any</p></blockquote></blockquote></div>"
},
"questionnaire" : "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire",
"status" : "completed",
"authored" : "2021-07-27T15:22:08.252Z",
"item" : [
{
"linkId" : "cr1",
"text" : "Research Study",
"item" : [
{
"linkId" : "cr1.1",
"text" : "Study Title",
"answer" : [
{
"valueString" : "A clinical study of the efficacy of Drug A"
}
]
},
{
"linkId" : "cr1.2",
"text" : "IRB Protocol Number",
"answer" : [
{
"valueString" : "A1234"
}
]
},
{
"linkId" : "cr1.3",
"text" : "Enrollment Status:",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "open",
"display" : "Open for enrollment"
}
}
]
},
{
"linkId" : "cr1.4",
"text" : "Intervention Status:",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "continue-meds",
"display" : "Continuing interventions"
}
}
]
},
{
"linkId" : "cr1.5",
"text" : "Study Status:",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/research-study-status",
"code" : "active",
"display" : "Active"
}
}
]
},
{
"linkId" : "cr1.6",
"text" : "Funding Source(check all that are applicable):",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "federal",
"display" : "Federal"
}
}
]
}
]
},
{
"linkId" : "cr2",
"text" : "Site Principal Investigator",
"item" : [
{
"linkId" : "cr2.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "Jane"
}
]
},
{
"linkId" : "cr2.4",
"text" : "Last Name",
"answer" : [
{
"valueString" : "Doe"
}
]
},
{
"linkId" : "cr2.6",
"text" : "Degree(s)",
"answer" : [
{
"valueString" : "MD"
}
]
},
{
"linkId" : "cr2.2",
"text" : "Phone",
"answer" : [
{
"valueString" : "111-555-1212"
}
]
},
{
"linkId" : "cr2.3",
"text" : "Email:",
"answer" : [
{
"valueString" : "xx@XX.edu"
}
]
}
]
},
{
"linkId" : "cr3a",
"text" : "Report Type",
"item" : [
{
"linkId" : "cr3a.1",
"text" : "Is this an initial report?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
}
]
},
{
"linkId" : "cr3",
"text" : "Accrual of Participants",
"item" : [
{
"linkId" : "cr3.1",
"text" : "Provide counts for the following:",
"item" : [
{
"linkId" : "cr3.1.1",
"text" : "Participants enrolled since activation:",
"answer" : [
{
"valueInteger" : 15
}
]
},
{
"linkId" : "cr3.1.2",
"text" : "Participants enrolled since last approval (or since study inception if initial review):",
"answer" : [
{
"valueInteger" : 15
}
]
},
{
"linkId" : "cr3.1.3",
"text" : "Participants approved to enroll:",
"answer" : [
{
"valueInteger" : 10
}
]
},
{
"linkId" : "cr3.1.4",
"text" : "Participants consented:",
"answer" : [
{
"valueInteger" : 10
}
]
},
{
"linkId" : "cr3.1.5",
"text" : "Participants withdrawn:",
"answer" : [
{
"valueInteger" : 1
}
]
},
{
"linkId" : "cr3.1.6",
"text" : "Participants lost to contact:"
},
{
"linkId" : "cr3.1.7",
"text" : "Participants with screen failures:",
"answer" : [
{
"valueInteger" : 100
}
]
},
{
"linkId" : "cr3.1.8",
"text" : "Participants still active or follow-up:",
"answer" : [
{
"valueInteger" : 9
}
]
},
{
"linkId" : "cr3.1.9",
"text" : "Participants completed study:"
},
{
"linkId" : "cr3.1.10",
"text" : "By Sex:",
"item" : [
{
"linkId" : "cr3.1.10.1",
"text" : "Men:",
"answer" : [
{
"valueInteger" : 4
}
]
},
{
"linkId" : "cr3.1.10.2",
"text" : "Women:",
"answer" : [
{
"valueInteger" : 5
}
]
}
]
},
{
"linkId" : "cr3.1.11",
"text" : "By Race",
"item" : [
{
"linkId" : "cr3.1.11.1",
"text" : "White:",
"answer" : [
{
"valueInteger" : 2
}
]
},
{
"linkId" : "cr3.1.11.2",
"text" : "Black or African American:",
"answer" : [
{
"valueInteger" : 3
}
]
},
{
"linkId" : "cr3.1.11.3",
"text" : "Asian:",
"answer" : [
{
"valueInteger" : 3
}
]
},
{
"linkId" : "cr3.1.11.5",
"text" : "Native Hawaiian or other Pacific Islander:",
"answer" : [
{
"valueInteger" : 1
}
]
}
]
},
{
"linkId" : "cr3.1.12",
"text" : "By Ethnicity",
"item" : [
{
"linkId" : "cr3.1.12.1",
"text" : "Hispanic or Latino:",
"answer" : [
{
"valueInteger" : 2
}
]
},
{
"linkId" : "cr3.1.12.2",
"text" : "Not Hispanic or Latino:",
"answer" : [
{
"valueInteger" : 7
}
]
}
]
}
]
},
{
"linkId" : "cr3.2",
"text" : "Vulnerable Populations",
"item" : [
{
"linkId" : "cr3.2.1",
"text" : "Number of potentially vulnerable participants enrolled:"
}
]
}
]
},
{
"linkId" : "cr4",
"text" : "Study Report",
"item" : [
{
"linkId" : "cr4.5",
"text" : "Since your last report (or since the study inception for an initial report):",
"item" : [
{
"linkId" : "cr4.5.1",
"text" : "Summarize the study progress:",
"answer" : [
{
"valueString" : "Study is started, continuing"
}
]
},
{
"linkId" : "cr4.5.2",
"text" : "Have participants experienced any benefits?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr4.5.4",
"text" : "Have participants been withdrawn from this study?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "cr4.5.5",
"text" : "If yes, please summarize the withdrawals:",
"answer" : [
{
"valueString" : "Participant Choice"
}
]
},
{
"linkId" : "cr4.5.6",
"text" : "Have any participants or others complained about the research?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr4.5.8",
"text" : "Has any new and relevant literature been published related to the risks or benefits associated with this research?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr4.5.10",
"text" : "Have there been any interim findings?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr4.5.12",
"text" : "Have there been any multi-center trial reports?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr4.5.14",
"text" : "Have there been any data safety monitoring board reports?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr4.5.16",
"text" : "In the opinion of the Principal Investigator, have the risks or potential benefits changed?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr4.5.18",
"text" : "Has an audit of the research been conducted by a federal agency or sponsor?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr4.5.19",
"text" : "Have there been any presentations or publications (including abstracts) from this research?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr4.5.20",
"text" : "Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "cr4.5.21",
"text" : "If yes, please summarize the changes:",
"answer" : [
{
"valueString" : "Modified allowance for blood draw amount."
}
]
},
{
"linkId" : "cr4.5.22",
"text" : "Was informed consent obtained from all enrolled participants?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "cr4.5.23",
"text" : "Has there been any other relevant information regarding this protocol?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
}
]
}
]
},
{
"linkId" : "cr5",
"text" : "Adverse Events",
"item" : [
{
"linkId" : "cr5.1",
"text" : "Have there been any internal or local adverse events in the research?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "cr5.3",
"text" : "Have any protocol deviations or violations occurred in this study?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
}
]
},
{
"linkId" : "cr6",
"text" : "Conflict of Interest",
"item" : [
{
"linkId" : "cr6.1",
"text" : "Has there been a change in the financial disclosure status of the Principal Investigator or other members of the Research Staff that has not been reported to the IRB?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
}
]
},
{
"linkId" : "ADMIN00",
"text" : "Administrative Use Only",
"item" : [
{
"linkId" : "ADMIN01",
"text" : "Link ID prefix",
"answer" : [
{
"valueString" : "cr"
}
]
},
{
"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, if any",
"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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