{ "description": null, "_filename": "example/Questionnaire-POPULATE-sirb-determination-letter-questionnaire.json", "package_name": "hl7.fhir.us.sirb", "subjectType": [ "ResearchStudy" ], "date": "2021-08-10T13:15:03+00:00", "meta": { "source": "#jomR6sVVIByhSJAs", "versionId": "6", "lastUpdated": "2021-07-20T16:23:42.027+00:00" }, "publisher": "HL7 International - BR&R Work Group", "jurisdiction": [ { "text": "United States of America", "coding": [ { "code": "US", "system": "urn:iso:std:iso:3166", "display": "United States of America" } ] } ], "name": "SIRBDeterminationQuestionnaire", "item": [ { "item": [ { "item": [ { "text": "Short Title of the Research Study", "type": "display", "linkId": "dl1.1_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Study Title", "type": "string", "linkId": "dl1.1", "required": true, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-d11.1", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.item.where(linkId = 'in1.2').answer.value" } } ] }, { "item": [ { "text": "IRB number assigned by the site institution", "type": "display", "linkId": "dl1.2_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "IRB Protocol Number", "type": "string", "linkId": "dl1.2", "required": false, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-d11.2", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.item.where(linkId = 'in1.3').answer.value" } } ] } ], "text": "Research Study", "type": "group", "linkId": "dl1", "required": false }, { "item": [ { "item": [ { "text": "IRB responsible for the overall approval of the study, and whose approval will then stand for the relying institutions in the network.", "type": "display", "linkId": "dl2.1_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] }, { "item": [ { "text": "Institution providing overall review of study for most sites enrolling participants in a researach study. Its role is to protect the rights and welfare of human research participants in research activities conducted; it has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction for all relying sites", "type": "display", "linkId": "dl2.1.1_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] }, { "text": "sIRB (Reviewing Institution) Name", "type": "string", "linkId": "dl2.1.1.1", "required": true, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.1.1.1", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.item.where(linkId = 'in6.1').answer.value" } } ] }, { "item": [ { "text": "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. Enter just the numeric value of the FWA.", "type": "display", "linkId": "dl2.1.1.2_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Federal Wide Assurance (FWA):", "type": "integer", "linkId": "dl2.1.1.2", "required": false, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.1.1.2", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.item.where(linkId = 'in6.9').answer.value" } } ] } ], "text": "Institution", "type": "group", "linkId": "dl2.1.1", "required": false }, { "item": [ { "text": "Main study personnel with which a study participant will interact. This may be also be the Site PI or a study coordinator or other site personnel.", "type": "display", "linkId": "dl2.1.2_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] }, { "item": [ { "text": "First or given name associated with the point of contact", "type": "display", "linkId": "dl2.1.2.1_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "First Name", "type": "string", "linkId": "dl2.1.2.1", "required": true }, { "item": [ { "text": "Surname or family name associated with the point of contact", "type": "display", "linkId": "dl2.1.2.2_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Last Name", "type": "string", "linkId": "dl2.1.2.2", "required": true }, { "item": [ { "text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the point of contact", "type": "display", "linkId": "d2.1.2.4_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Suffix", "type": "string", "linkId": "dl2.1.2.4", "repeats": false, "readOnly": false, "required": false }, { "item": [ { "text": "Professional and Academic degrees associated with the point of contact", "type": "display", "linkId": "dl2.1.2.5_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Professional Degree(s)", "type": "string", "linkId": "dl2.1.2.5", "repeats": false, "readOnly": false, "required": false }, { "text": "Email", "type": "string", "linkId": "dl2.1.2.3", "required": true } ], "text": "Point of Contact", "type": "group", "linkId": "dl2.1.2", "required": false }, { "item": [ { "text": "Principal Investigator responsible for the conduct of the study overall; oversees all participating sites", "type": "display", "linkId": "dl2.1.3_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] }, { "item": [ { "text": "First or Given name associated with the overall principal investigator", "type": "display", "linkId": "dl2.1.3.1_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "First Name", "type": "string", "linkId": "dl2.1.3.1", "required": true, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.1.3.1", "language": "text/fhirpath", "expression": "QuestionnaireResponse.item.item.where(linkId = 'in7.1').answer.value" } } ] }, { "item": [ { "text": "Surname or family name associated with the overall principal investigator", "type": "display", "linkId": "dl2.1.3.2_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Last Name", "type": "string", "linkId": "dl2.1.3.2", "required": true, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.1.3.2", "language": "text/fhirpath", "expression": "QuestionnaireResponse.item.item.where(linkId = 'in7.2').answer.value" } } ] }, { "item": [ { "text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the overall principal investigator's name", "type": "display", "linkId": "dl2.1.3.4_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Suffix", "type": "string", "linkId": "dl2.1.3.4", "repeats": false, "readOnly": false, "required": false, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.1.3.4", "language": "text/fhirpath", "expression": "QuestionnaireResponse.item.item.where(linkId = 'in7.3').answer.value" } } ] }, { "item": [ { "text": "Professional and Academic degrees associated with the overall principal investigator", "type": "display", "linkId": "dl2.1.3.5_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Degree(s)", "type": "string", "linkId": "dl2.1.3.5", "repeats": false, "readOnly": false, "required": false, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.1.3.5", "language": "text/fhirpath", "expression": "QuestionnaireResponse.item.item.where(linkId = 'in7.4').answer.value" } } ] }, { "text": "Email", "type": "string", "linkId": "dl2.1.3.3", "required": true, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.1.3.3", "language": "text/fhirpath", "expression": "QuestionnaireResponse.item.item.where(linkId = 'in7.13').answer.value" } } ] } ], "text": "Overall Principal Investigator", "type": "group", "linkId": "dl2.1.3", "repeats": false, "readOnly": false, "required": false } ], "text": "sIRB (Reviewing Institution)", "type": "group", "linkId": "dl2.1", "required": false }, { "text": "Determination Decision", "type": "choice", "linkId": "dl2.2", "required": true, "answerOption": [ { "valueCoding": { "code": "AR", "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes", "display": "Accepts Review" } }, { "valueCoding": { "code": "DR", "system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes", "display": "Denies Review" } } ] }, { "item": [ { "text": "IRB relying on the decisions of the reviewing IRB", "type": "display", "linkId": "dl2.3_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] }, { "item": [ { "text": "Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.", "type": "display", "linkId": "dl2.3.1_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] }, { "text": "Name", "type": "choice", "linkId": "dl2.3.1.1", "required": true, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-answerExpression", "valueExpression": { "name": "dataToPopulate-dl2.3.1.1", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.item.item.where(linkId = 'in8.1.1').answer.value" } } ] }, { "item": [ { "text": "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.", "type": "display", "linkId": "dl2.3.1.2_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Federal Wide Assurance (FWA)", "type": "integer", "linkId": "dl2.3.1.2", "required": false, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.3.1.2", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite)).item.where(linkId = 'in8.1').item.where(linkId = 'in8.1.5').answer.value" } } ] } ], "text": "Institution", "type": "group", "linkId": "dl2.3.1", "required": false }, { "item": [ { "text": "Investigator responsible for the conduct of the study at a specific research location.", "type": "display", "linkId": "dl2.3.2_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] }, { "item": [ { "text": "First or Given name associated with the site investigator", "type": "display", "linkId": "dl2.3.2.1_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "First Name", "type": "string", "linkId": "dl2.3.2.1", "required": true, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.3.2.1", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.1').answer.value" } } ] }, { "item": [ { "text": "Surname or family name associated with the site investigator", "type": "display", "linkId": "dl2.3.2.2_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Last Name", "type": "string", "linkId": "dl2.3.2.2", "required": true, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.3.2.2", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.2').answer.value" } } ] }, { "item": [ { "text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator's name", "type": "display", "linkId": "dl2.3.2.4_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Suffix", "type": "string", "linkId": "dl2.3.2.4", "repeats": false, "readOnly": false, "required": false, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.3.2.4", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.3').answer.value" } } ] }, { "item": [ { "text": "Professional and Academic degrees associated with the site investigator", "type": "display", "linkId": "dl2.3.2.5_help", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl", "valueCodeableConcept": { "coding": [ { "code": "help", "system": "http://hl7.org/fhir/questionnaire-item-control", "display": "Help-Button" } ] } } ] } ], "text": "Professional Degree(s)", "type": "string", "linkId": "dl2.3.2.5", "repeats": false, "readOnly": false, "required": false, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.3.2.5", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.4').answer.value" } } ] }, { "text": "Email", "type": "string", "linkId": "dl2.3.2.3", "required": true, "extension": [ { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-dl2.3.2.3", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.where(item.item.where(linkId = 'in8.1.1' and answer.value = %valueSelected-RelyingSite )).item.where(linkId = 'in8.3').item.where(linkId = 'in8.3.4').answer.value" } } ] } ], "text": "Site Principal Investigator", "type": "group", "linkId": "dl2.3.2", "required": false } ], "text": "Relying IRB", "type": "group", "linkId": "dl2.3", "required": false, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/variable", "valueExpression": { "name": "valueSelected-RelyingSite", "language": "text/fhirpath", "expression": "%resource.item.item.item.item.where(linkId = 'dl2.3.1.1').answer.value" } } ] } ], "text": "Reliance Determination", "type": "group", "linkId": "dl2", "required": false }, { "item": [ { "text": "Link ID prefix", "type": "string", "linkId": "ADMIN01", "initial": [ { "valueString": "dl" } ], "required": false, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden", "valueBoolean": true } ] }, { "text": "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any", "type": "string", "linkId": "ADMIN02", "required": false, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden", "valueBoolean": true }, { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-ADMIN02", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.item.where(linkId = 'ADMIN02').answer.value" } } ] }, { "text": "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any", "type": "string", "linkId": "ADMIN03", "initial": [ { "valueString": "temporarily unavailable" } ], "required": false, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden", "valueBoolean": true }, { "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", "valueExpression": { "name": "dataToPopulate-ADMIN03", "language": "text/fhirpath", "expression": "%lookupInitiateStudy.item.item.where(linkId = 'ADMIN03').answer.value" } } ] }, { "text": "Questionnaire Response ID of the local considerations Questionnaire Response, if any", "type": "string", "linkId": "ADMIN04", "required": false, "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden", "valueBoolean": true } ] } ], "text": "Administrative Use Only", "type": "group", "linkId": "ADMIN00", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden", "valueBoolean": true } ] } ], "type": null, "experimental": "false", "resourceType": "Questionnaire", "title": "sIRB Determination Questionnaire", "package_version": "0.1.0", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/variable", "valueExpression": { "name": "lookupInitiateStudy", "language": "application/x-fhir-query", "expression": "https://docr-fhir.dev.cloud.duke.edu/hapi-fhir-jpaserver/fhir/QuestionnaireResponse/QRIDInitiateStudy", "description": "response to get the data from" } } ], "status": "draft", "id": "48644dfd-626c-47c2-84ba-0eaaf31cd6d8", "kind": null, "url": "https://build.fhir.org/ig/HL7/fhir-sirb/Questionnaire-POPULATE-sirb-determination-letter-questionnaire.html", "version": "0.1.0", "contact": [ { "name": "HL7 International - Biomedical Research and Regulation", "telecom": [ { "value": "http://www.hl7.org/Special/committees/rcrim", "system": "url" } ] } ] }