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 
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:QuestionnaireResponse;
fhir:nodeRole fhir:treeRoot;
fhir:Resource.id [ fhir:value "MEDICAL-AE-QR"];
fhir:Resource.meta [
fhir:Meta.versionId [ fhir:value "1" ];
fhir:Meta.lastUpdated [ fhir:value "2021-07-23T21:09:31.112+00:00"^^xsd:dateTime ];
fhir:Meta.source [ fhir:value "#pgbjyveyUglHxqGY" ]
];
fhir:DomainResource.text [
fhir:Narrative.status [ fhir:value "generated" ];
fhir:Narrative.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>"
];
fhir:QuestionnaireResponse.questionnaire [
fhir:value "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire";
fhir:link <http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire>
];
fhir:QuestionnaireResponse.status [ fhir:value "completed"];
fhir:QuestionnaireResponse.authored [ fhir:value "2021-07-23T16:36:24.459Z"^^xsd:dateTime];
fhir:QuestionnaireResponse.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "RESEARCH STUDY" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Title" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "A study comparison of Treatment A and B" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "IRB Protocol Number" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "PRO098765" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae1.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Type" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "INT" ];
fhir:Coding.display [ fhir:value "Interventional" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae1.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Does this protocol require an FDA exemption?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae1.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is an IND or IDE being used in this study?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ]
], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site Principal Investigator" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "First Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Mike" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae2.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Last Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Medical" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae2.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Degree(s)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MD" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae2.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "111-555-1213" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae2.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Email" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "mike.medical.email2.citymedical.edu" ] ] ]
], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Primary Contact" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "First Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Ben" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Last Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Coordinator" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae3.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "111-555-1212" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae3.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Email" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "ben.coordinator@centralsamplehosp.org" ] ] ]
], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site/Organization" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae4.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of organization/site where the event occurred" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Central Sample Hospital" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae4.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name of organization/site which is recording the Adverse Medical event" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "City Medical University" ] ] ]
], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participant Information" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Patient ID" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "12345" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Age" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "58" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Birth Sex" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0001" ];
fhir:Coding.code [ fhir:value "M" ];
fhir:Coding.display [ fhir:value "Male" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Weight" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueQuantity [
fhir:Quantity.value [ fhir:value "245"^^xsd:decimal ];
fhir:Quantity.unit [ fhir:value "[lb]" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Height" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueQuantity [
fhir:Quantity.value [ fhir:value "67"^^xsd:decimal ];
fhir:Quantity.unit [ fhir:value "[in]" ] ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Ethnicity" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Ethnicity" ];
fhir:Coding.code [ fhir:value "2186-5" ];
fhir:Coding.display [ fhir:value "Not Hispanic or Latino" ] ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Race" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Race" ];
fhir:Coding.code [ fhir:value "2106-3" ];
fhir:Coding.display [ fhir:value "White" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v3-Race" ];
fhir:Coding.code [ fhir:value "2054-5" ];
fhir:Coding.display [ fhir:value "Black or African American" ] ] ] ], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Which Arm/Cohort/treatment group was the participant assigned to (if known)?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "unknown" ] ] ], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participant dosed or received study agent" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "NI" ];
fhir:Coding.display [ fhir:value "No Information" ] ] ] ], [
fhir:index 9;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae5.11" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Were there any Protocol Deviations/Violations/Exceptions for this participant?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ]
], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Adverse Medical Event Information" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Submission Type" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes" ];
fhir:Coding.code [ fhir:value "INITIAL" ];
fhir:Coding.display [ fhir:value "Initial" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Start Date" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-01-05"^^xsd:date ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Reported Date" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-11-06"^^xsd:date ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Recorded Date" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-11-06"^^xsd:date ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.5a" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Narrative of the Adverse Event:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Blood clot developed in right leg after several days of inactivity. Participant experienced swelling and pain." ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.5b" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Medical Description of Adverse Event" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Deep Vein Thrombosis" ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is the Adverse Medical event still ongoing?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Stop Date" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-01-05"^^xsd:date ] ] ], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was the event expected?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0239" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 9;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Severity" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-severity" ];
fhir:Coding.code [ fhir:value "mild" ];
fhir:Coding.display [ fhir:value "Mild" ] ] ] ], [
fhir:index 10;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.10" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is the Adverse Medical Event Serious?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness" ];
fhir:Coding.code [ fhir:value "serious" ];
fhir:Coding.display [ fhir:value "Serious" ] ] ] ], [
fhir:index 11;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.11" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Seriousness" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0240" ];
fhir:Coding.code [ fhir:value "H" ];
fhir:Coding.display [ fhir:value "Caused hospitalized" ] ] ] ], [
fhir:index 12;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.12" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "What is the date Adverse Medical Event became serious?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-01-05"^^xsd:date ] ] ], [
fhir:index 13;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.13" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Outcome of Adverse Medical Event" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0241" ];
fhir:Coding.code [ fhir:value "F" ];
fhir:Coding.display [ fhir:value "Fully recovered" ] ] ] ], [
fhir:index 14;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.15" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relationship of Adverse Medical Event to Study Intervention" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0250" ];
fhir:Coding.code [ fhir:value "S" ];
fhir:Coding.display [ fhir:value "Somewhat probable" ] ] ] ], [
fhir:index 15;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.16" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Rationale for relationship with study intervention" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "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." ] ] ], [
fhir:index 16;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.23" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Action Taken Regarding Study Intervention" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0251" ];
fhir:Coding.code [ fhir:value "WT" ];
fhir:Coding.display [ fhir:value "Product withdrawn temporarily" ] ] ] ], [
fhir:index 17;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.24" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 18;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.25" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If study intervention was restarted (rechallenge) did AE recur?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ], [
fhir:index 19;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.26" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Did the participant receive any relevant concomitant medications in response to the SAE?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 20;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.27" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "SAE Concomitant Medications" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.28.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Medication Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "warfarin" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.28.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Indication" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "anticoagulant" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.28.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Start Date" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-01-05"^^xsd:date ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.28.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Stop Date" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-04-04"^^xsd:date ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.28.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Ongoing" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ] ], [
fhir:index 21;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae6.29" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Did the participant receive any treatments/procedures in response to the SAE?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "N" ];
fhir:Coding.display [ fhir:value "No" ] ] ] ]
], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/v2-0532" ];
fhir:Coding.code [ fhir:value "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ]
], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "SAE Laboratory or Diagnostic Tests" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae8.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Lab/Diagnostic Test" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "ultrasound" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae8.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Date" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-01-05"^^xsd:date ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae8.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Result" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "positive" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae8.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Low Range" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "-" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae8.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "High Range" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "-" ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "mae8.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Comments" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "blood clot noted" ] ] ]
], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN00" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Administrative Use Only" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN01" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Link ID prefix" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "mae" ] ] ]
].
# - ontology header ------------------------------------------------------------
a owl:Ontology;
owl:imports fhir:fhir.ttl.
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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