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 "INITIATE-QR"];
fhir:Resource.meta [
fhir:Meta.versionId [ fhir:value "2" ];
fhir:Meta.lastUpdated [ fhir:value "2021-07-25T19:47:30.979+00:00"^^xsd:dateTime ];
fhir:Meta.source [ fhir:value "#jPrXQW4xZAW3qV7B" ]
];
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-initiate-study-questionnaire\">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire</a></p><p><b>status</b>: completed</p><p><b>authored</b>: Jul 23, 2021 5:52:41 AM</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in1</p><p><b>text</b>: Research Study Details</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in1.1</p><p><b>text</b>: Study Title</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in1.2</p><p><b>text</b>: Study Title (Short)</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in1.3</p><p><b>text</b>: IRB Protocol Number</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in1.4</p><p><b>text</b>: Study Type</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5</p><p><b>text</b>: Other Organization(s) Involved</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.1</p><p><b>text</b>: Relationship Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.2</p><p><b>text</b>: Organization Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.3</p><p><b>text</b>: Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.4</p><p><b>text</b>: Sponsor or Funding Source Protocol Number, if applicable</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5</p><p><b>text</b>: Other Organization(s) Involved</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.1</p><p><b>text</b>: Relationship Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.2</p><p><b>text</b>: Organization Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.3</p><p><b>text</b>: Phone</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5</p><p><b>text</b>: Other Organization(s) Involved</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.1</p><p><b>text</b>: Relationship Type</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.2</p><p><b>text</b>: Organization Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in5.3</p><p><b>text</b>: Phone</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6</p><p><b>text</b>: sIRB (Reviewing Institution)</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.1</p><p><b>text</b>: sIRB (Reviewing Institution) Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.3</p><p><b>text</b>: Institution Street Address</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.4</p><p><b>text</b>: Institution City</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.5</p><p><b>text</b>: Institution State</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.6</p><p><b>text</b>: Institution Zip Code</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.7</p><p><b>text</b>: Institution Country</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.8</p><p><b>text</b>: Is a Federal Wide Assurance (FWA) Number assigned?</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in6.9</p><p><b>text</b>: Federal Wide Assurance Number (if assigned)</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7</p><p><b>text</b>: Overall Principal Investigator for the Study</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.1</p><p><b>text</b>: Overall Principal Investigator First Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.2</p><p><b>text</b>: Overall Principal Investigator Last Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.3</p><p><b>text</b>: Overall Principal Investigator Suffix</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.4</p><p><b>text</b>: Academic and Professional Degrees associated with the Overall Principal Investigator</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.5</p><p><b>text</b>: Overall Principal Investigator Institution Name</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.6</p><p><b>text</b>: Department Name or Division</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.7</p><p><b>text</b>: Street Address</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.8</p><p><b>text</b>: City</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.9</p><p><b>text</b>: State</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.10</p><p><b>text</b>: Zip Code</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.11</p><p><b>text</b>: Country</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.12</p><p><b>text</b>: Overall Principal Investigator Phone</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in7.13</p><p><b>text</b>: Overall Principal Investigator Email Address</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in8</p><p><b>text</b>: Confirmed or Potential Relying Site(s)</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in8.1</p><p><b>text</b>: Confirmed or Potential Relying Site Overview</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in8.3</p><p><b>text</b>: Site Principal Investigator at Relying Site</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in8</p><p><b>text</b>: Confirmed or Potential Relying Site(s)</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in8.1</p><p><b>text</b>: Confirmed or Potential Relying Site Overview</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in8.3</p><p><b>text</b>: Site Principal Investigator at Relying Site</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in9</p><p><b>text</b>: Questionnaire Version Details</p><blockquote><p><b>item</b></p><p><b>linkId</b>: in9.1</p><p><b>text</b>: Questionnaire Version</p></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: in9.2</p><p><b>text</b>: Questionnaire Version Date</p></blockquote></blockquote><blockquote><p><b>item</b></p><p><b>linkId</b>: ADMIN00</p><p><b>text</b>: Administrative Use Only (will be hidden in the future)</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</p></blockquote></blockquote></div>"
];
fhir:QuestionnaireResponse.questionnaire [
fhir:value "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire";
fhir:link <http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire>
];
fhir:QuestionnaireResponse.status [ fhir:value "completed"];
fhir:QuestionnaireResponse.authored [ fhir:value "2021-07-23T05:52:41.328Z"^^xsd:dateTime];
fhir:QuestionnaireResponse.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Research Study Details" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Title" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Double blind, placebo-controlled trial of a new class of arthritis medication" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in1.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Study Title (Short)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Testing a new arthritis medication" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in1.3" ];
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 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in1.4" ];
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 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Other Organization(s) Involved" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relationship 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 "SFS" ];
fhir:Coding.display [ fhir:value "Sponsor or Funding Source" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Organization Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "NIH" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "800-123-1234" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Sponsor or Funding Source Protocol Number, if applicable" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "NIH-2021-123456" ] ] ]
], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Other Organization(s) Involved" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relationship 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 "SFS" ];
fhir:Coding.display [ fhir:value "Sponsor or Funding Source" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Organization Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Organization of Arthritis Patients Foundatio" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "123-123-1234" ] ] ]
], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Other Organization(s) Involved" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relationship 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 "CRO" ];
fhir:Coding.display [ fhir:value "Contract Research Organization (CRO)" ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Organization Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Sample CRO, Inc." ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in5.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "234-123-1234" ] ] ]
], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "sIRB (Reviewing Institution)" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in6.1" ];
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 "in6.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Institution Street Address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "100 Sample University Drive" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in6.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Institution City" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Sample City" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in6.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Institution State" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "NC" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in6.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Institution Zip Code" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "12345" ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in6.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Institution Country" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "United States" ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in6.8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is a Federal Wide Assurance (FWA) Number assigned?" ];
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 "in6.9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Federal Wide Assurance Number (if assigned)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "56789"^^xsd:integer ] ] ]
], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Overall Principal Investigator for the Study" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Overall Principal Investigator 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 "in7.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Overall Principal Investigator 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 "in7.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Overall Principal Investigator 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 "in7.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Academic and Professional Degrees associated with the Overall Principal Investigator" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MD" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Overall Principal Investigator Institution Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Sample University Medical Center" ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Department Name or Division" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Orthopedics" ] ] ], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Street Address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "105 Sample University Ct." ] ] ], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "City" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Sample City" ] ] ], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "State" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "NC" ] ] ], [
fhir:index 9;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.10" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Zip Code" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "12345" ] ] ], [
fhir:index 10;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.11" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Country" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "United States" ] ] ], [
fhir:index 11;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.12" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Overall Principal Investigator Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "567-123-1234" ] ] ], [
fhir:index 12;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in7.13" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Overall Principal Investigator Email Address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "drjohndoe@sampleuniversity.edu" ] ] ]
], [
fhir:index 6;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Confirmed or Potential Relying Site(s)" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Confirmed or Potential Relying Site Overview" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Institution 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 "in8.1.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Institution Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "6781233456" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is a Federal Wide Assurance (FWA) Number assigned?" ];
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 "in8.1.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Federal Wide Assurance Number (if assigned)" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueInteger [ fhir:value "34567"^^xsd:integer ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Reliance 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 "APPROVED" ];
fhir:Coding.display [ fhir:value "Approved for reliance" ] ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Site Address" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Street Address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "100 Test Example Circle" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "City" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Example" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "State" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MA" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Zip Code" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "67890" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Country" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "United States" ] ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site Principal Investigator at Relying Site" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Site Principal Investigator 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 "in8.3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Site Principal Investigator 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 "in8.3.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Academic and Professional Degrees associated with the Relying Site Principal Investigator" ];
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 "in8.3.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "6781233456" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Email address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "xi.lee@teu.med.ed" ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Address of Relying Site Principal Investigator" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Street Address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "200 Test Example Circle" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "City" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Example" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "State" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MA" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Zip Code" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "67890" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Country" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "United States" ] ] ] ] ]
], [
fhir:index 7;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Confirmed or Potential Relying Site(s)" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Confirmed or Potential Relying Site Overview" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Institution Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Central Campus Test University" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Institution Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "8901231234" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Is a Federal Wide Assurance (FWA) Number assigned?" ];
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 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Reliance 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 "POSSIBLE" ];
fhir:Coding.display [ fhir:value "Potential/possible" ] ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Site Address" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Street Address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "100 Central St." ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "City" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Central" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "State" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MI" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Zip Code" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "23456" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.1.7.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Country" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "United States" ] ] ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Site Principal Investigator at Relying Site" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Site Principal Investigator First Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Maria" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Relying Site Principal Investigator Last Name" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Smith" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Academic and Professional Degrees associated with the Relying Site Principal Investigator" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "PhD" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Phone" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "8901231234" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.6" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Email address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "maria.smith@CCTU.med.edu" ] ] ], [
fhir:index 5;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Address of Relying Site Principal Investigator" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Street Address" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "200 Central St." ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "City" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "Central" ] ] ], [
fhir:index 2;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.3" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "State" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "MI" ] ] ], [
fhir:index 3;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.4" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Zip Code" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "23456" ] ] ], [
fhir:index 4;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in8.3.7.5" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Country" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "United States" ] ] ] ] ]
], [
fhir:index 8;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in9" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Questionnaire Version Details" ];
fhir:QuestionnaireResponse.item.item [
fhir:index 0;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in9.1" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Questionnaire Version" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueString [ fhir:value "1" ] ] ], [
fhir:index 1;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "in9.2" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Questionnaire Version Date" ];
fhir:QuestionnaireResponse.item.answer [
fhir:index 0;
fhir:QuestionnaireResponse.item.answer.valueDate [ fhir:value "2021-06-01"^^xsd:date ] ] ]
], [
fhir:index 9;
fhir:QuestionnaireResponse.item.linkId [ fhir:value "ADMIN00" ];
fhir:QuestionnaireResponse.item.text [ fhir:value "Administrative Use Only (will be hidden in the future)" ];
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 "in" ] ] ], [
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" ];
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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