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 "CONTINUING-REVIEW-QR"];
fhir:Resource.meta [
fhir:Meta.versionId [ fhir:value "2" ];
fhir:Meta.lastUpdated [ fhir:value "2021-07-28T19:30:37.109+00:00"^^xsd:dateTime ];
fhir:Meta.source [ fhir:value "#p17nsc0DW6GRC5C3" ]
];
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-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>"
];
fhir:QuestionnaireResponse.questionnaire [
fhir:value "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire";
fhir:link <http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire>
];
fhir:QuestionnaireResponse.status [ fhir:value "completed"];
fhir:QuestionnaireResponse.authored [ fhir:value "2021-07-27T15:22:08.252Z"^^xsd:dateTime];
fhir:QuestionnaireResponse.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Research Study" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Title" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "A clinical study of the efficacy of Drug A" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "IRB Protocol Number" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "A1234" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr1.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Enrollment Status:" ];
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 "open" ];
fhir:Coding.display [ fhir:value "Open for enrollment" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr1.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Intervention Status:" ];
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 "continue-meds" ];
fhir:Coding.display [ fhir:value "Continuing interventions" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr1.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Status:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueCoding [
fhir:Coding.system [ fhir:value "http://hl7.org/fhir/research-study-status" ];
fhir:Coding.code [ fhir:value "active" ];
fhir:Coding.display [ fhir:value "Active" ] ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr1.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Funding Source(check all that are applicable):" ];
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 "federal" ];
fhir:Coding.display [ fhir:value "Federal" ] ] ] ]
], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site Principal Investigator" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "First Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Jane" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr2.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Last Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Doe" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr2.6" ];
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 "cr2.2" ];
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 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr2.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Email:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "xx@XX.edu" ] ] ]
], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3a" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Report Type" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3a.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is this an initial report?" ];
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 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Accrual of Participants" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Provide counts for the following:" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participants enrolled since activation:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "15"^^xsd:integer ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participants enrolled since last approval (or since study inception if initial review):" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "15"^^xsd:integer ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participants approved to enroll:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "10"^^xsd:integer ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participants consented:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "10"^^xsd:integer ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participants withdrawn:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "1"^^xsd:integer ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participants lost to contact:" ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participants with screen failures:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "100"^^xsd:integer ] ] ], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participants still active or follow-up:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "9"^^xsd:integer ] ] ], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Participants completed study:" ] ], [
fhir:index 9;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.10" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "By Sex:" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.10.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Men:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "4"^^xsd:integer ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.10.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Women:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "5"^^xsd:integer ] ] ] ], [
fhir:index 10;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.11" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "By Race" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.11.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "White:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "2"^^xsd:integer ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.11.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Black or African American:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "3"^^xsd:integer ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.11.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Asian:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "3"^^xsd:integer ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.11.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Native Hawaiian or other Pacific Islander:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "1"^^xsd:integer ] ] ] ], [
fhir:index 11;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.12" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "By Ethnicity" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.12.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Hispanic or Latino:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "2"^^xsd:integer ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.1.12.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Not Hispanic or Latino:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "7"^^xsd:integer ] ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Vulnerable Populations" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr3.2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Number of potentially vulnerable participants enrolled:" ] ] ]
], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Report" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Since your last report (or since the study inception for an initial report):" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Summarize the study progress:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Study is started, continuing" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have participants experienced any benefits?" ];
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 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have participants been withdrawn from 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 "Y" ];
fhir:Coding.display [ fhir:value "Yes" ] ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If yes, please summarize the withdrawals:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Participant Choice" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have any participants or others complained about the research?" ];
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 "cr4.5.8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Has any new and relevant literature been published related to the risks or benefits associated with this research?" ];
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 "cr4.5.10" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have there been any interim findings?" ];
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 "cr4.5.12" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have there been any multi-center trial reports?" ];
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 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.14" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have there been any data safety monitoring board reports?" ];
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 9;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.16" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "In the opinion of the Principal Investigator, have the risks or potential benefits changed?" ];
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 10;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.18" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Has an audit of the research been conducted by a federal agency or sponsor?" ];
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 11;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.19" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have there been any presentations or publications (including abstracts) from this research?" ];
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 12;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.20" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?" ];
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 13;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.21" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "If yes, please summarize the changes:" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Modified allowance for blood draw amount." ] ] ], [
fhir:index 14;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.22" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Was informed consent obtained from all enrolled participants?" ];
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 15;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr4.5.23" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Has there been any other relevant information regarding this protocol?" ];
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 "cr5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Adverse Events" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr5.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have there been any internal or local adverse events in the research?" ];
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 "cr5.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Have any protocol deviations or violations occurred 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 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Conflict of Interest" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "cr6.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "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?" ];
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 "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 "cr" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN02" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "temporarily unavailable" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN03" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "temporarily unavailable" ] ] ]
].
# - 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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