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 "DETERMINATION-QR"];
fhir:Resource.meta [
fhir:Meta.versionId [ fhir:value "2" ];
fhir:Meta.lastUpdated [ fhir:value "2021-07-27T15:48:47.066+00:00"^^xsd:dateTime ];
fhir:Meta.source [ fhir:value "#HVWOJN3tCJYGmPWD" ]
];
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-determination-letter-questionnaire\">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 3:23:55 PM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: dl1</p><p><b>text</b>: Research Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: dl1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: dl1.2</p><p><b>text</b>: IRB Protocol Number</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: dl2</p><p><b>text</b>: Reliance Determination</p><blockquote><p><b>item</b></p><p><b>linkId</b>: dl2.1</p><p><b>text</b>: sIRB (Reviewing Institution)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: dl2.2</p><p><b>text</b>: Determination Decision</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: dl2.3</p><p><b>text</b>: Relying 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></div>"
];
fhir:QuestionnaireResponse.questionnaire [
fhir:value "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire";
fhir:link <http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire>
];
fhir:QuestionnaireResponse.status [ fhir:value "completed"];
fhir:QuestionnaireResponse.authored [ fhir:value "2021-07-23T15:23:55.475Z"^^xsd:dateTime];
fhir:QuestionnaireResponse.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Research Study" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Title" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Testing a new arthritis medication" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "IRB Protocol Number" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "SUMC-1234567" ] ] ]
], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Reliance Determination" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "sIRB (Reviewing Institution)" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Institution" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "sIRB (Reviewing Institution) Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Sample University Medical Center" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Federal Wide Assurance (FWA):" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "56789"^^xsd:integer ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Point of Contact" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "First Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "John" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.2.2" ];
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 "dl2.1.2.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Suffix" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "IV" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.2.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Professional Degree(s)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MD" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.2.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Email" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "drjohndoe@sampleuniversity.edu" ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Overall Principal Investigator" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "First Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "John" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.3.2" ];
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 "dl2.1.3.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Suffix" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "IV" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.3.5" ];
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 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.1.3.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Email" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "drjohndoe@sampleuniversity.edu" ] ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Determination Decision" ];
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 "AR" ];
fhir:Coding.display [ fhir:value "Accepts Review" ] ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying IRB" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Institution" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.3.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Test Example University" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.3.1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Federal Wide Assurance (FWA)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "34567"^^xsd:integer ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site Principal Investigator" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.3.2.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "First Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Xi" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.3.2.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Last Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Lee" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.3.2.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Professional Degree(s)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MD, PhD" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "dl2.3.2.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Email" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "xi.lee@teu.med.edu" ] ] ] ] ]
], [
fhir:index 2;
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 "dl" ] ] ]
].
# - 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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