{
"description": null,
"_filename": "example/Questionnaire-sirb-continuing-review-questionnaire.json",
"package_name": "hl7.fhir.us.sirb",
"subjectType": [ "ResearchStudy" ],
"date": "2021-08-10T13:15:03+00:00",
"meta": {
"source": "#f7YRqGXah3dM364r",
"versionId": "14",
"lastUpdated": "2021-07-28T23:42:09.371+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": "Continuing_review",
"item": [ {
"item": [ {
"item": [ {
"text": "Study Title from the Informed Consent",
"type": "display",
"linkId": "cr1.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Study Title",
"type": "string",
"linkId": "cr1.1",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Number assigned to the protocol by IRB",
"type": "display",
"linkId": "cr1.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "IRB Protocol Number",
"type": "string",
"linkId": "cr1.2",
"required": false
}, {
"text": "Enrollment Status:",
"type": "choice",
"linkId": "cr1.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "not-open",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Not yet open"
}
}, {
"valueCoding": {
"code": "open-no-participants",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Open with no participants"
}
}, {
"valueCoding": {
"code": "open",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Open for enrollment"
}
}, {
"valueCoding": {
"code": "closed",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Closed to enrollment"
}
} ]
}, {
"item": [ {
"text": "Current intervention status. This can be used by the IRB to determine that continuing review is no longer required.",
"type": "display",
"linkId": "cr1.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Intervention Status:",
"type": "choice",
"linkId": "cr1.4",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "complete",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "All interventions complete"
}
}, {
"valueCoding": {
"code": "continue-meds",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Continuing interventions"
}
}, {
"valueCoding": {
"code": "continue-min-risk",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Continuing interventions - minimal risk"
}
} ]
}, {
"item": [ {
"text": "Status of the study overall. Study Status can also be used by the IRB to determine that continuing review is no longer required.",
"type": "display",
"linkId": "cr1.5_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Study Status:",
"type": "choice",
"linkId": "cr1.5",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "active",
"system": "http://hl7.org/fhir/research-study-status",
"display": "Active"
}
}, {
"valueCoding": {
"code": "disapproved",
"system": "http://hl7.org/fhir/research-study-status",
"display": "Disapproved"
}
}, {
"valueCoding": {
"code": "closed-to-accrual",
"system": "http://hl7.org/fhir/research-study-status",
"display": "Closed to Accrual"
}
}, {
"valueCoding": {
"code": "closed-to-accrual-and-intervention",
"system": "http://hl7.org/fhir/research-study-status",
"display": "Closed to Accrual and Intervention"
}
}, {
"valueCoding": {
"code": "completed",
"system": "http://hl7.org/fhir/research-study-status",
"display": "Completed"
}
}, {
"valueCoding": {
"code": "administratively-completed",
"system": "http://hl7.org/fhir/research-study-status",
"display": "Administratively Completed"
}
}, {
"valueCoding": {
"code": "temporarily-closed-to-accrual",
"system": "http://hl7.org/fhir/research-study-status",
"display": "Temporarily Closed to Accrual"
}
}, {
"valueCoding": {
"code": "temporarily-closed-to-accrual-and-intervention",
"system": "http://hl7.org/fhir/research-study-status",
"display": "Temporarily Closed to Accrual and Intervention"
}
}, {
"valueCoding": {
"code": "withdrawn",
"system": "http://hl7.org/fhir/research-study-status",
"display": "Withdrawn"
}
} ]
}, {
"item": [ {
"text": "The funding source for the study. Note that a single study can have multiple funding sources and that the funding sources can change over time.",
"type": "display",
"linkId": "cr1.6_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
}, {
"text": "Other-Please specify:",
"type": "text",
"linkId": "cr1.6.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "cr1.6",
"answerCoding": {
"code": "otherfund",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ]
} ],
"text": "Funding Source(check all that are applicable):",
"type": "open-choice",
"linkId": "cr1.6",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Check-box",
"coding": [ {
"code": "check-box",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Check-box"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "vertical"
} ],
"answerOption": [ {
"valueCoding": {
"code": "federal",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Federal"
}
}, {
"valueCoding": {
"code": "state",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "State"
}
}, {
"valueCoding": {
"code": "industry",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Industry"
}
}, {
"valueCoding": {
"code": "foundation",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Foundation"
}
}, {
"valueCoding": {
"code": "institutional",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Institutional"
}
}, {
"valueCoding": {
"code": "departmental",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Departmental"
}
}, {
"valueCoding": {
"code": "otherfund",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Other Funding Source"
}
} ]
} ],
"text": "Research Study",
"type": "group",
"linkId": "cr1",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"item": [ {
"text": "First or given name associated with the site principal investigator",
"type": "display",
"linkId": "cr2.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "First Name",
"type": "string",
"linkId": "cr2.1",
"required": false
}, {
"item": [ {
"text": "Surname or family name associated with the site principal investigator",
"type": "display",
"linkId": "cr2.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Last Name",
"type": "string",
"linkId": "cr2.4",
"repeats": false,
"readOnly": false,
"required": false
}, {
"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": "cr2.5_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Suffix",
"type": "string",
"linkId": "cr2.5",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Professional and Academic degrees associated with the site principal investigator",
"type": "display",
"linkId": "cr2.6_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Degree(s)",
"type": "string",
"linkId": "cr2.6",
"repeats": false,
"readOnly": false,
"required": false
}, {
"text": "Phone",
"type": "string",
"linkId": "cr2.2",
"required": false
}, {
"text": "Email:",
"type": "string",
"linkId": "cr2.3",
"required": false
} ],
"text": "Site Principal Investigator",
"type": "group",
"linkId": "cr2",
"required": false
}, {
"item": [ {
"item": [ {
"text": "An initial report is the first time that the study is reviewed.",
"type": "display",
"linkId": "cr3a.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Is this an initial report?",
"type": "choice",
"linkId": "cr3a.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
} ],
"text": "Report Type",
"type": "group",
"linkId": "cr3a",
"repeats": false,
"required": false
}, {
"item": [ {
"text": "The number of participants who are enrolled, approved to enroll, consented, withdrawn, lost to contact, are screen failures, are active or in follow-up , or completed study",
"type": "display",
"linkId": "cr3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
}, {
"item": [ {
"text": "How many participants there are in each category",
"type": "display",
"linkId": "cr3.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
}, {
"text": "Participants enrolled since activation:",
"type": "integer",
"linkId": "cr3.1.1",
"required": false
}, {
"text": "Participants enrolled since last approval (or since study inception if initial review):",
"type": "integer",
"linkId": "cr3.1.2",
"required": false
}, {
"text": "Participants approved to enroll:",
"type": "integer",
"linkId": "cr3.1.3",
"required": false
}, {
"text": "Participants consented:",
"type": "integer",
"linkId": "cr3.1.4",
"required": false
}, {
"text": "Participants withdrawn:",
"type": "integer",
"linkId": "cr3.1.5",
"required": false
}, {
"text": "Participants lost to contact:",
"type": "integer",
"linkId": "cr3.1.6",
"required": false
}, {
"text": "Participants with screen failures:",
"type": "integer",
"linkId": "cr3.1.7",
"required": false
}, {
"text": "Participants still active or follow-up:",
"type": "integer",
"linkId": "cr3.1.8",
"required": false
}, {
"text": "Participants completed study:",
"type": "integer",
"linkId": "cr3.1.9",
"required": false
}, {
"item": [ {
"text": "Men:",
"type": "integer",
"linkId": "cr3.1.10.1",
"required": false
}, {
"text": "Women:",
"type": "integer",
"linkId": "cr3.1.10.2",
"required": false
} ],
"text": "By Sex:",
"type": "group",
"linkId": "cr3.1.10",
"required": false
}, {
"item": [ {
"text": "White:",
"type": "integer",
"linkId": "cr3.1.11.1",
"required": false
}, {
"text": "Black or African American:",
"type": "integer",
"linkId": "cr3.1.11.2",
"required": false
}, {
"text": "Asian:",
"type": "integer",
"linkId": "cr3.1.11.3",
"required": false
}, {
"text": "American Indian or Alaska Native:",
"type": "integer",
"linkId": "cr3.1.11.4",
"required": false
}, {
"text": "Native Hawaiian or other Pacific Islander:",
"type": "integer",
"linkId": "cr3.1.11.5",
"required": false
}, {
"text": "More than One Race:",
"type": "integer",
"linkId": "cr3.1.11.6",
"required": false
}, {
"text": "Unknown/Not Reported:",
"type": "integer",
"linkId": "cr3.1.11.7",
"required": false
} ],
"text": "By Race",
"type": "group",
"linkId": "cr3.1.11",
"required": false
}, {
"item": [ {
"text": "Hispanic or Latino:",
"type": "integer",
"linkId": "cr3.1.12.1",
"required": false
}, {
"text": "Not Hispanic or Latino:",
"type": "integer",
"linkId": "cr3.1.12.2",
"required": false
}, {
"text": "Unknown/Not Reported:",
"type": "integer",
"linkId": "cr3.1.12.3",
"required": false
} ],
"text": "By Ethnicity",
"type": "group",
"linkId": "cr3.1.12",
"required": false
} ],
"text": "Provide counts for the following:",
"type": "group",
"linkId": "cr3.1",
"required": false
}, {
"item": [ {
"text": "Number of potentially vulnerable participants enrolled:",
"type": "integer",
"linkId": "cr3.2.1",
"required": false
}, {
"item": [ {
"text": "Children",
"type": "boolean",
"linkId": "cr3.2.2.1",
"required": false
}, {
"text": "Cognitively Impaired",
"type": "boolean",
"linkId": "cr3.2.2.2",
"required": false
}, {
"text": "Employees",
"type": "boolean",
"linkId": "cr3.2.2.3",
"required": false
}, {
"text": "Fetuses",
"type": "boolean",
"linkId": "cr3.2.2.4",
"required": false
}, {
"text": "Neonates (non-viable / uncertain viability)",
"type": "boolean",
"linkId": "cr3.2.2.5",
"required": false
}, {
"text": "Pregnant Women",
"type": "boolean",
"linkId": "cr3.2.2.6",
"required": false
}, {
"text": "Prisoners",
"type": "boolean",
"linkId": "cr3.2.2.7",
"required": false
}, {
"text": "Students",
"type": "boolean",
"linkId": "cr3.2.2.8",
"required": false
} ],
"text": "Check all that apply:",
"type": "group",
"linkId": "cr3.2.2",
"required": false
}, {
"text": "Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests. (CIOMS)",
"type": "display",
"linkId": "cr3.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Vulnerable Populations",
"type": "group",
"linkId": "cr3.2",
"required": false
} ],
"text": "Accrual of Participants",
"type": "group",
"linkId": "cr3",
"required": false
}, {
"item": [ {
"item": [ {
"item": [ {
"text": "Summary of activities in the study (since the last report if this is not an initial review)",
"type": "display",
"linkId": "cr4.5.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Summarize the study progress:",
"type": "text",
"linkId": "cr4.5.1",
"required": false
}, {
"item": [ {
"text": "Indicator of benefits to participants",
"type": "display",
"linkId": "cr4.5.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Have participants experienced any benefits?",
"type": "choice",
"linkId": "cr4.5.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize the benefits:",
"type": "text",
"linkId": "cr4.5.3",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.2",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Have participants been withdrawn from this study?",
"type": "choice",
"linkId": "cr4.5.4",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize the withdrawals:",
"type": "text",
"linkId": "cr4.5.5",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.4",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Have any participants or others complained about the research?",
"type": "choice",
"linkId": "cr4.5.6",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize the complaints:",
"type": "text",
"linkId": "cr4.5.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.6",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "literature published related to the risks or benefits associated with this research",
"type": "display",
"linkId": "cr4.5.8_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Has any new and relevant literature been published related to the risks or benefits associated with this research?",
"type": "choice",
"linkId": "cr4.5.8",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize relevance to study:",
"type": "text",
"linkId": "cr4.5.9",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Have there been any interim findings?",
"type": "choice",
"linkId": "cr4.5.10",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize findings:",
"type": "text",
"linkId": "cr4.5.11",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.10",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Have there been any multi-center trial reports?",
"type": "choice",
"linkId": "cr4.5.12",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize findings and recommendations",
"type": "text",
"linkId": "cr4.5.13",
"repeats": false,
"readOnly": false,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.12",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Have there been any data safety monitoring board reports?",
"type": "choice",
"linkId": "cr4.5.14",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize findings and recommendations:",
"type": "text",
"linkId": "cr4.5.15",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.14",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "In the opinion of the Principal Investigator, have the risks or potential benefits changed?",
"type": "choice",
"linkId": "cr4.5.16",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize the changes:",
"type": "text",
"linkId": "cr4.5.17",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.16",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Has an audit of the research been conducted by a federal agency or sponsor?",
"type": "choice",
"linkId": "cr4.5.18",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "Have there been any presentations or publications (including abstracts) from this research?",
"type": "choice",
"linkId": "cr4.5.19",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "Have there been any substantial changes to the study (protocol, consent forms, or other study documents) or to the risk-benefit assessment?",
"type": "choice",
"linkId": "cr4.5.20",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize the changes:",
"type": "text",
"linkId": "cr4.5.21",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.20",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Was informed consent obtained from all enrolled participants?",
"type": "choice",
"linkId": "cr4.5.22",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "Has there been any other relevant information regarding this protocol?",
"type": "choice",
"linkId": "cr4.5.23",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please summarize:",
"type": "text",
"linkId": "cr4.5.24",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr4.5.23",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Since your last report (or since the study inception for an initial report):",
"type": "group",
"linkId": "cr4.5",
"required": false,
"enableBehavior": "all"
} ],
"text": "Study Report",
"type": "group",
"linkId": "cr4",
"required": false
}, {
"item": [ {
"text": "Summary of adverse events during the previous continuing review period (or since the study inception for an initial report)",
"type": "display",
"linkId": "cr5_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
}, {
"text": "Have there been any internal or local adverse events in the research?",
"type": "choice",
"linkId": "cr5.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "Did these adverse events occur at the frequency and level of severity expected?",
"type": "choice",
"linkId": "cr5.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "cr5.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "Have any protocol deviations or violations occurred in this study?",
"type": "choice",
"linkId": "cr5.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
} ],
"text": "Adverse Events",
"type": "group",
"linkId": "cr5",
"required": false
}, {
"item": [ {
"text": "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?",
"type": "choice",
"linkId": "cr6.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "If yes, please explain:",
"type": "text",
"linkId": "cr6.2",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr6.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Conflict of Interest",
"type": "group",
"linkId": "cr6",
"required": false
}, {
"item": [ {
"text": "Link ID prefix",
"type": "string",
"linkId": "ADMIN01",
"initial": [ {
"valueString": "cr"
} ],
"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",
"initial": [ {
"valueString": "temporarily unavailable"
} ],
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
}, {
"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
} ]
}, {
"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": null,
"resourceType": "Questionnaire",
"title": "Continuing Review",
"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": "ff9aa168-b141-4bb3-acb7-6d4f578bd265",
"kind": null,
"url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire",
"version": "0.1.0",
"contact": [ {
"name": "HL7 International - Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ]
}