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" : "MEDICAL-AE-QR",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2021-07-23T21:09:31.112+00:00",
"source" : "#pgbjyveyUglHxqGY"
},
"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-adverse-event-questionnaire\">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 4:36:24 PM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1</p><p><b>text</b>: RESEARCH STUDY</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.2</p><p><b>text</b>: IRB Protocol Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.3</p><p><b>text</b>: Study Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.4</p><p><b>text</b>: Does this protocol require an FDA exemption?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae1.5</p><p><b>text</b>: Is an IND or IDE being used in this study?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2</p><p><b>text</b>: Site Principal Investigator</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.1</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.2</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.6</p><p><b>text</b>: Degree(s)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.3</p><p><b>text</b>: Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae2.4</p><p><b>text</b>: Email</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3</p><p><b>text</b>: Primary Contact</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3.1</p><p><b>text</b>: First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3.2</p><p><b>text</b>: Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3.3</p><p><b>text</b>: Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae3.4</p><p><b>text</b>: Email</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae4</p><p><b>text</b>: Site/Organization</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae4.1</p><p><b>text</b>: Name of organization/site where the event occurred</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae4.2</p><p><b>text</b>: Name of organization/site which is recording the Adverse Medical event</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5</p><p><b>text</b>: Participant Information</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.1</p><p><b>text</b>: Patient ID</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.2</p><p><b>text</b>: Age</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.3</p><p><b>text</b>: Birth Sex</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.4</p><p><b>text</b>: Weight</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.5</p><p><b>text</b>: Height</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.6</p><p><b>text</b>: Ethnicity</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.7</p><p><b>text</b>: Race</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.8</p><p><b>text</b>: Which Arm/Cohort/treatment group was the participant assigned to (if known)?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.9</p><p><b>text</b>: Participant dosed or received study agent</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae5.11</p><p><b>text</b>: Were there any Protocol Deviations/Violations/Exceptions for this participant?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6</p><p><b>text</b>: Adverse Medical Event Information</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.1</p><p><b>text</b>: Submission Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.2</p><p><b>text</b>: Start Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.3</p><p><b>text</b>: Reported Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.4</p><p><b>text</b>: Recorded Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.5a</p><p><b>text</b>: Narrative of the Adverse Event:</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.5b</p><p><b>text</b>: Medical Description of Adverse Event</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.6</p><p><b>text</b>: Is the Adverse Medical event still ongoing?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.7</p><p><b>text</b>: Stop Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.8</p><p><b>text</b>: Was the event expected?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.9</p><p><b>text</b>: Severity</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.10</p><p><b>text</b>: Is the Adverse Medical Event Serious?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.11</p><p><b>text</b>: Seriousness</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.12</p><p><b>text</b>: What is the date Adverse Medical Event became serious?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.13</p><p><b>text</b>: Outcome of Adverse Medical Event</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.15</p><p><b>text</b>: Relationship of Adverse Medical Event to Study Intervention</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.16</p><p><b>text</b>: Rationale for relationship with study intervention</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.23</p><p><b>text</b>: Action Taken Regarding Study Intervention</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.24</p><p><b>text</b>: If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.25</p><p><b>text</b>: If study intervention was restarted (rechallenge) did AE recur?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.26</p><p><b>text</b>: Did the participant receive any relevant concomitant medications in response to the SAE?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.27</p><p><b>text</b>: SAE Concomitant Medications</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae6.29</p><p><b>text</b>: Did the participant receive any treatments/procedures in response to the SAE?</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae7</p><p><b>text</b>: Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?</p><h3>Answers</h3><table class=\"grid\"><tr><td>-</td><td><b>Value[x]</b></td></tr><tr><td>*</td><td><span title=\"{http://terminology.hl7.org/CodeSystem/v2-0532 Y}\">Yes</span></td></tr></table></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8</p><p><b>text</b>: SAE Laboratory or Diagnostic Tests</p><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.1</p><p><b>text</b>: Lab/Diagnostic Test</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.2</p><p><b>text</b>: Date</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.3</p><p><b>text</b>: Result</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.4</p><p><b>text</b>: Low Range</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.5</p><p><b>text</b>: High Range</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: mae8.6</p><p><b>text</b>: Comments</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-adverse-event-questionnaire",
"status" : "completed",
"authored" : "2021-07-23T16:36:24.459Z",
"item" : [
{
"linkId" : "mae1",
"text" : "RESEARCH STUDY",
"item" : [
{
"linkId" : "mae1.1",
"text" : "Study Title",
"answer" : [
{
"valueString" : "A study comparison of Treatment A and B"
}
]
},
{
"linkId" : "mae1.2",
"text" : "IRB Protocol Number",
"answer" : [
{
"valueString" : "PRO098765"
}
]
},
{
"linkId" : "mae1.3",
"text" : "Study Type",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "INT",
"display" : "Interventional"
}
}
]
},
{
"linkId" : "mae1.4",
"text" : "Does this protocol require an FDA exemption?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "mae1.5",
"text" : "Is an IND or IDE being used in this study?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
}
]
},
{
"linkId" : "mae2",
"text" : "Site Principal Investigator",
"item" : [
{
"linkId" : "mae2.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "Mike"
}
]
},
{
"linkId" : "mae2.2",
"text" : "Last Name",
"answer" : [
{
"valueString" : "Medical"
}
]
},
{
"linkId" : "mae2.6",
"text" : "Degree(s)",
"answer" : [
{
"valueString" : "MD"
}
]
},
{
"linkId" : "mae2.3",
"text" : "Phone",
"answer" : [
{
"valueString" : "111-555-1213"
}
]
},
{
"linkId" : "mae2.4",
"text" : "Email",
"answer" : [
{
"valueString" : "mike.medical.email2.citymedical.edu"
}
]
}
]
},
{
"linkId" : "mae3",
"text" : "Primary Contact",
"item" : [
{
"linkId" : "mae3.1",
"text" : "First Name",
"answer" : [
{
"valueString" : "Ben"
}
]
},
{
"linkId" : "mae3.2",
"text" : "Last Name",
"answer" : [
{
"valueString" : "Coordinator"
}
]
},
{
"linkId" : "mae3.3",
"text" : "Phone",
"answer" : [
{
"valueString" : "111-555-1212"
}
]
},
{
"linkId" : "mae3.4",
"text" : "Email",
"answer" : [
{
"valueString" : "ben.coordinator@centralsamplehosp.org"
}
]
}
]
},
{
"linkId" : "mae4",
"text" : "Site/Organization",
"item" : [
{
"linkId" : "mae4.1",
"text" : "Name of organization/site where the event occurred",
"answer" : [
{
"valueString" : "Central Sample Hospital"
}
]
},
{
"linkId" : "mae4.2",
"text" : "Name of organization/site which is recording the Adverse Medical event",
"answer" : [
{
"valueString" : "City Medical University"
}
]
}
]
},
{
"linkId" : "mae5",
"text" : "Participant Information",
"item" : [
{
"linkId" : "mae5.1",
"text" : "Patient ID",
"answer" : [
{
"valueString" : "12345"
}
]
},
{
"linkId" : "mae5.2",
"text" : "Age",
"answer" : [
{
"valueString" : "58"
}
]
},
{
"linkId" : "mae5.3",
"text" : "Birth Sex",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0001",
"code" : "M",
"display" : "Male"
}
}
]
},
{
"linkId" : "mae5.4",
"text" : "Weight",
"answer" : [
{
"valueQuantity" : {
"value" : 245,
"unit" : "[lb]"
}
}
]
},
{
"linkId" : "mae5.5",
"text" : "Height",
"answer" : [
{
"valueQuantity" : {
"value" : 67,
"unit" : "[in]"
}
}
]
},
{
"linkId" : "mae5.6",
"text" : "Ethnicity",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v3-Ethnicity",
"code" : "2186-5",
"display" : "Not Hispanic or Latino"
}
}
]
},
{
"linkId" : "mae5.7",
"text" : "Race",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v3-Race",
"code" : "2106-3",
"display" : "White"
}
},
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v3-Race",
"code" : "2054-5",
"display" : "Black or African American"
}
}
]
},
{
"linkId" : "mae5.8",
"text" : "Which Arm/Cohort/treatment group was the participant assigned to (if known)?",
"answer" : [
{
"valueString" : "unknown"
}
]
},
{
"linkId" : "mae5.9",
"text" : "Participant dosed or received study agent",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "NI",
"display" : "No Information"
}
}
]
},
{
"linkId" : "mae5.11",
"text" : "Were there any Protocol Deviations/Violations/Exceptions for this participant?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
}
]
},
{
"linkId" : "mae6",
"text" : "Adverse Medical Event Information",
"item" : [
{
"linkId" : "mae6.1",
"text" : "Submission Type",
"answer" : [
{
"valueCoding" : {
"system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code" : "INITIAL",
"display" : "Initial"
}
}
]
},
{
"linkId" : "mae6.2",
"text" : "Start Date",
"answer" : [
{
"valueDate" : "2021-01-05"
}
]
},
{
"linkId" : "mae6.3",
"text" : "Reported Date",
"answer" : [
{
"valueDate" : "2021-11-06"
}
]
},
{
"linkId" : "mae6.4",
"text" : "Recorded Date",
"answer" : [
{
"valueDate" : "2021-11-06"
}
]
},
{
"linkId" : "mae6.5a",
"text" : "Narrative of the Adverse Event:",
"answer" : [
{
"valueString" : "Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain."
}
]
},
{
"linkId" : "mae6.5b",
"text" : "Medical Description of Adverse Event",
"answer" : [
{
"valueString" : "Deep Vein Thrombosis"
}
]
},
{
"linkId" : "mae6.6",
"text" : "Is the Adverse Medical event still ongoing?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "mae6.7",
"text" : "Stop Date",
"answer" : [
{
"valueDate" : "2021-01-05"
}
]
},
{
"linkId" : "mae6.8",
"text" : "Was the event expected?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0239",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "mae6.9",
"text" : "Severity",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
"code" : "mild",
"display" : "Mild"
}
}
]
},
{
"linkId" : "mae6.10",
"text" : "Is the Adverse Medical Event Serious?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code" : "serious",
"display" : "Serious"
}
}
]
},
{
"linkId" : "mae6.11",
"text" : "Seriousness",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0240",
"code" : "H",
"display" : "Caused hospitalized"
}
}
]
},
{
"linkId" : "mae6.12",
"text" : "What is the date Adverse Medical Event became serious?",
"answer" : [
{
"valueDate" : "2021-01-05"
}
]
},
{
"linkId" : "mae6.13",
"text" : "Outcome of Adverse Medical Event",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0241",
"code" : "F",
"display" : "Fully recovered"
}
}
]
},
{
"linkId" : "mae6.15",
"text" : "Relationship of Adverse Medical Event to Study Intervention",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0250",
"code" : "S",
"display" : "Somewhat probable"
}
}
]
},
{
"linkId" : "mae6.16",
"text" : "Rationale for relationship with study intervention",
"answer" : [
{
"valueString" : "Neither treatment A nor treatment B have known increased risks of blood clots. Patient was inactive for several days which might have been the cause."
}
]
},
{
"linkId" : "mae6.23",
"text" : "Action Taken Regarding Study Intervention",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0251",
"code" : "WT",
"display" : "Product withdrawn temporarily"
}
}
]
},
{
"linkId" : "mae6.24",
"text" : "If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "mae6.25",
"text" : "If study intervention was restarted (rechallenge) did AE recur?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
},
{
"linkId" : "mae6.26",
"text" : "Did the participant receive any relevant concomitant medications in response to the SAE?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "mae6.27",
"text" : "SAE Concomitant Medications",
"item" : [
{
"linkId" : "mae6.28.1",
"text" : "Medication Name",
"answer" : [
{
"valueString" : "warfarin"
}
]
},
{
"linkId" : "mae6.28.2",
"text" : "Indication",
"answer" : [
{
"valueString" : "anticoagulant"
}
]
},
{
"linkId" : "mae6.28.3",
"text" : "Start Date",
"answer" : [
{
"valueDate" : "2021-01-05"
}
]
},
{
"linkId" : "mae6.28.4",
"text" : "Stop Date",
"answer" : [
{
"valueDate" : "2021-04-04"
}
]
},
{
"linkId" : "mae6.28.5",
"text" : "Ongoing",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
}
]
},
{
"linkId" : "mae6.29",
"text" : "Did the participant receive any treatments/procedures in response to the SAE?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "N",
"display" : "No"
}
}
]
}
]
},
{
"linkId" : "mae7",
"text" : "Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?",
"answer" : [
{
"valueCoding" : {
"system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
"code" : "Y",
"display" : "Yes"
}
}
]
},
{
"linkId" : "mae8",
"text" : "SAE Laboratory or Diagnostic Tests",
"item" : [
{
"linkId" : "mae8.1",
"text" : "Lab/Diagnostic Test",
"answer" : [
{
"valueString" : "ultrasound"
}
]
},
{
"linkId" : "mae8.2",
"text" : "Date",
"answer" : [
{
"valueDate" : "2021-01-05"
}
]
},
{
"linkId" : "mae8.3",
"text" : "Result",
"answer" : [
{
"valueString" : "positive"
}
]
},
{
"linkId" : "mae8.4",
"text" : "Low Range",
"answer" : [
{
"valueString" : "-"
}
]
},
{
"linkId" : "mae8.5",
"text" : "High Range",
"answer" : [
{
"valueString" : "-"
}
]
},
{
"linkId" : "mae8.6",
"text" : "Comments",
"answer" : [
{
"valueString" : "blood clot noted"
}
]
}
]
},
{
"linkId" : "ADMIN00",
"text" : "Administrative Use Only",
"item" : [
{
"linkId" : "ADMIN01",
"text" : "Link ID prefix",
"answer" : [
{
"valueString" : "mae"
}
]
}
]
}
]
}
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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