{
"description": null,
"_filename": "Questionnaire-sirb-continuing-review-questionnaire-populate.json",
"package_name": "hl7.fhir.us.sirb",
"subjectType": [ "ResearchStudy" ],
"date": "2023-04-20T13:44:05+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",
"readOnly": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value"
}
} ]
}, {
"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,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value"
}
} ]
}, {
"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": "Funding Source(check all that are applicable)",
"type": "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": "Other Funding Source-Please specify:",
"type": "string",
"linkId": "cr1.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr1.6",
"answerCoding": {
"code": "otherfund",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ]
} ],
"text": "Research Study",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr1",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "sIRB (Reviewing Institution) Name",
"type": "string",
"linkId": "cr12.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value"
}
} ]
} ],
"text": "sIRB (Reviewing Institution)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr12",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Select \"Yes\" if this Continuing Review Form is being completed by the lead principal investigator site, the study coordinating center or other administrative unit on behalf of all the relying sites in the overall study.",
"type": "display",
"linkId": "cr9.1_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 Continuing Review Form being submitted by the lead PI site on behalf of all of the relying sites?",
"type": "choice",
"linkId": "cr9.1",
"required": true,
"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": "External Data For linkId cr9.2",
"type": "open-choice",
"linkId": "ExternalDataFor_cr9.2",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/designNote",
"valueMarkdown": "See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."
} ]
}, {
"item": [ {
"text": "This question and its answer will not print on the Continuing Review Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.",
"type": "display",
"linkId": "cr9.2_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": "If this Continuing Review Form is specific to a relying site, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.",
"type": "choice",
"linkId": "cr9.2",
"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"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-answerExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.repeat(item).where(linkId = 'ExternalDataFor_cr9.2').answer.value"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/designNote",
"valueMarkdown": "See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."
} ],
"enableWhen": [ {
"operator": "=",
"question": "cr9.1",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Submission Type",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr9",
"required": false
}, {
"item": [ {
"text": "Site Principal Investigator Institution Name",
"type": "string",
"linkId": "cr11.1",
"required": true,
"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"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value)"
}
} ]
}, {
"text": "Institution Department Name or Division",
"type": "string",
"linkId": "cr11.2",
"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"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.10').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.1.10').answer.value)"
}
} ]
} ],
"text": "Site Principal Investigator Institution",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr11",
"required": false
}, {
"item": [ {
"item": [ {
"text": "First or given name of 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,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Surname or family name",
"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",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.",
"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",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Professional and Academic degrees of 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",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value)"
}
} ]
}, {
"text": "Site Principal Investigator Department Name or Division",
"type": "string",
"linkId": "cr2.10",
"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"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.10').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.10').answer.value)"
}
} ]
}, {
"item": [ {
"text": "10-digit phone number, including area code",
"type": "display",
"linkId": "cr2.2_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": "Phone",
"type": "string",
"linkId": "cr2.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Email address for site PI",
"type": "display",
"linkId": "cr2.3_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": "Email",
"type": "string",
"linkId": "cr2.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%overallCRForm = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %siteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value)"
}
} ]
} ],
"text": "Site Principal Investigator",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr2",
"required": false
}, {
"item": [ {
"item": [ {
"text": "An initial report is the first time that the study is reviewed.",
"type": "display",
"linkId": "cr7.1_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": "cr7.1",
"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",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr7",
"repeats": false,
"required": false
}, {
"item": [ {
"text": "The number of participants who are enrolled, approved to enroll, consented, withdrawn, lost to contact, screen failures, 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": "If this is an initial review, provide counts since study inception. The count for the Previous Accrual should be entered as 0 when completing the questionnaire for the initial report.",
"type": "display",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#5caf42; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.15",
"enableWhen": [ {
"operator": "=",
"question": "cr7.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.1.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.1.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.1.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.1.1').answer.value + %resource.descendants().where(linkId = 'cr3.1.1.2').answer.value"
}
} ]
} ],
"text": "Participants enrolled since activation",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.31"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.2.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.2.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.2.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.2.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Participants enrolled since last approval",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.32"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.3.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.3.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.3.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.3.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Participants approved to enroll",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.33"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.4.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.4.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.4.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.4.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.4.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Participants consented",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.4",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.34"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.5.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.5.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.5.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.5.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.5.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Participants withdrawn",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.5",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.35"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.6.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.6.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.6.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.6.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.6.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Participants lost to contact",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.6",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.36"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.7.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.7.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.7.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.7.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.7.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Participants with screen failures",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.7",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.37"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.8.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.8.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.8.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.8.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.8.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Participants still active or follow-up",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.8",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.38"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.9.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.9.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.9.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.9.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.9.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Participants completed study",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.9",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.39"
}, {
"item": [ {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.10.1.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.10.1.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.10.1.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.10.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.10.1.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Men",
"type": "group",
"linkId": "cr3.1.10.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.10.31"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.10.2.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.10.2.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.10.2.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.10.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.10.2.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Women",
"type": "group",
"linkId": "cr3.1.10.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
} ],
"text": "By Sex",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.10",
"required": false
}, {
"type": "display",
"linkId": "cr3.1.40"
}, {
"item": [ {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.11.1.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.11.1.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.11.1.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.11.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.1.2').answer.value.toInteger()"
}
} ]
} ],
"text": "White",
"type": "group",
"linkId": "cr3.1.11.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.11.31"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.11.2.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.11.2.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.11.2.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.11.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.2.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Black or African American",
"type": "group",
"linkId": "cr3.1.11.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.11.32"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.11.3.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.11.3.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.11.3.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.11.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.3.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Asian",
"type": "group",
"linkId": "cr3.1.11.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.11.33"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.11.4.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.11.4.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.11.4.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.11.4.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.4.2').answer.value.toInteger()"
}
} ]
} ],
"text": "American Indian or Alaska Native",
"type": "group",
"linkId": "cr3.1.11.4",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.11.34"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.11.5.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.11.5.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.11.5.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.11.5.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.5.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Native Hawaiian or other Pacific Islander",
"type": "group",
"linkId": "cr3.1.11.5",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.11.35"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.11.6.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.11.6.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.11.6.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.11.6.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.6.2').answer.value.toInteger()"
}
} ]
} ],
"text": "More than One Race",
"type": "group",
"linkId": "cr3.1.11.6",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.11.36"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.11.7.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.11.7.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.11.7.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.11.7.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.11.7.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Unknown/Not Reported",
"type": "group",
"linkId": "cr3.1.11.7",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
} ],
"text": "By Race",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.11",
"required": false
}, {
"type": "display",
"linkId": "cr3.1.41"
}, {
"item": [ {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.12.1.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.12.1.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.12.1.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.12.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.1.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Hispanic or Latino",
"type": "group",
"linkId": "cr3.1.12.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.12.31"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.12.2.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.12.2.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.12.2.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.12.2.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.2.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Not Hispanic or Latino",
"type": "group",
"linkId": "cr3.1.12.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "cr3.1.12.32"
}, {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.1.12.3.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.1.12.3.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.1.12.3.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.1.12.3.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.1.12.3.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Unknown/Not Reported",
"type": "group",
"linkId": "cr3.1.12.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
} ],
"text": "By Ethnicity",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.1.12",
"required": false
}, {
"type": "display",
"linkId": "cr3.1.42"
}, {
"text": "Number of participants by 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": "Provide counts for the following",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "cr3.1",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Previous Accrual",
"type": "integer",
"linkId": "cr3.2.1.1"
}, {
"text": "Additional enrollees this approval period",
"type": "integer",
"linkId": "cr3.2.1.2"
}, {
"text": "Total",
"type": "integer",
"linkId": "cr3.2.1.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr3.2.1.1').answer.value.toInteger() + %resource.descendants().where(linkId = 'cr3.2.1.2').answer.value.toInteger()"
}
} ]
} ],
"text": "Number of potentially vulnerable participants enrolled",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.2.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 115%"
} ]
}, {
"type": "display",
"linkId": "cr3.2.30"
}, {
"item": [ {
"text": "For an initial report, skip the checkboxes for Previous Accrual",
"type": "display",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#5caf42; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr3.2.2.15",
"enableWhen": [ {
"operator": "=",
"question": "cr7.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Children",
"type": "choice",
"linkId": "cr3.2.2.1",
"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": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Previous Accrual"
}
}, {
"valueCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Additional enrollees this approval period"
}
} ]
}, {
"text": "Cognitively Impaired",
"type": "choice",
"linkId": "cr3.2.2.2",
"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": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Previous Accrual"
}
}, {
"valueCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Additional enrollees this approval period"
}
} ]
}, {
"text": "Employees",
"type": "choice",
"linkId": "cr3.2.2.3",
"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": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Previous Accrual"
}
}, {
"valueCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Additional enrollees this approval period"
}
} ]
}, {
"text": "Fetuses",
"type": "choice",
"linkId": "cr3.2.2.4",
"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": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Previous Accrual"
}
}, {
"valueCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Additional enrollees this approval period"
}
} ]
}, {
"text": "Neonates (non-viable / uncertain viability)",
"type": "choice",
"linkId": "cr3.2.2.5",
"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": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Previous Accrual"
}
}, {
"valueCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Additional enrollees this approval period"
}
} ]
}, {
"text": "Pregnant Women",
"type": "choice",
"linkId": "cr3.2.2.6",
"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": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Previous Accrual"
}
}, {
"valueCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Additional enrollees this approval period"
}
} ]
}, {
"text": "Prisoners",
"type": "choice",
"linkId": "cr3.2.2.7",
"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": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Previous Accrual"
}
}, {
"valueCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Additional enrollees this approval period"
}
} ]
}, {
"text": "Students",
"type": "choice",
"linkId": "cr3.2.2.8",
"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": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Previous Accrual"
}
}, {
"valueCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Additional enrollees this approval period"
}
} ]
}, {
"text": "Other",
"type": "choice",
"linkId": "cr3.2.2.9",
"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": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Previous Accrual"
}
}, {
"valueCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Additional enrollees this approval period"
}
} ]
}, {
"text": "Please describe other vulnerable participants enrolled, if any:",
"type": "text",
"linkId": "cr3.2.2.10",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr3.2.2.9",
"answerCoding": {
"code": "PreviousAccrual",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
}, {
"operator": "=",
"question": "cr3.2.2.9",
"answerCoding": {
"code": "AdditionalEnrollees",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ],
"enableBehavior": "any"
} ],
"text": "Check the applicable checkboxes if these groups are represented in the columns above",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"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",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "cr3.2",
"required": false
} ],
"text": "Accrual of Participants",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr3",
"required": false
}, {
"item": [ {
"item": [ {
"text": "(since the study inception for an initial report)",
"type": "display",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#5caf42; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "cr4.5.50",
"enableWhen": [ {
"operator": "=",
"question": "cr7.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"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:",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "cr4.5",
"required": false
} ],
"text": "Study Report",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr4",
"required": false
}, {
"item": [ {
"text": "Any adverse events (medical and/or non-medical) 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": "If no, please explain:",
"type": "text",
"linkId": "cr5.12",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr5.2",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"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": "If yes, please describe the protocol deviations or violations",
"type": "text",
"linkId": "cr5.13",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "cr5.3",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Adverse Events",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"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",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr6",
"required": false
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "cr17.1"
}, {
"text": "Attachment",
"type": "attachment",
"linkId": "cr17.2"
}, {
"text": "Attachments related to the Continuing Review can be included here. Examples are a DSMB report or an Adverse Event Report (Medical or Non-Medical).",
"type": "display",
"linkId": "cr17_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": "Attachments",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "cr17",
"repeats": true,
"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
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().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": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().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": null,
"resourceType": "Questionnaire",
"title": "Continuing Review",
"package_version": "1.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-launchContext",
"extension": [ {
"url": "name",
"valueCoding": {
"code": "sourceQuestionnaireResponse",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "The content of the Questionnaire Response transferred to this Questionnaire during form launch"
}
}, {
"url": "type",
"valueCode": "QuestionnaireResponse"
}, {
"url": "description",
"valueString": "The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire"
} ]
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "lookupInitiateStudy",
"language": "text/fhirpath",
"expression": "%sourceQuestionnaireResponse",
"description": "variable to store the incoming data from the launchContext extension for populate and other expressions"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "overallCRForm",
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr9.1').answer.valueCoding.code",
"description": "submission type (overall study or site-specific)"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "siteForForm",
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'cr9.2').answer.valueCoding.display",
"description": "site that this Continuing Review form pertains to"
}
} ],
"status": "draft",
"id": "104dec3a-7df9-4196-bd4d-63d59881289a",
"kind": null,
"url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-continuing-review-questionnaire-populate",
"version": "1.0.0",
"contact": [ {
"name": "HL7 International - Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ]
}