FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | ODB MS NON STR.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Questionnaire",
"id": "86b98847-0f22-4fd2-b23a-3b6793dcdf5a",
"meta": {
"versionId": "1",
"lastUpdated": "2024-07-26T15:17:01.110+00:00",
"source": "#smileutil-b9fcdf",
"profile": [
"https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-Questionnaire|1.0.0"
]
},
"version": "3.0.10",
"title": "OFI MS NON STR",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"description": "OFI MS NON STR",
"code": [
{
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Internal-Request-Category-Types",
"code": "REQUEST-CATEGORY-DRUG-SUBMISSION",
"display": "Drug Submission"
},
{
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Internal-Product-Types",
"code": "PRODUCT-MULTI-SOURCE",
"display": "Multiple Source"
},
{
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Internal-Submission-Types",
"code": "SUB-GENERIC-PRODUCT",
"display": "New Generic Product"
},
{
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Generic-Classification",
"code": "NEW-GENERIC-OFI-NON-STREAMLINED",
"display": "OFI - New Non-Streamlined Product"
},
{
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Questionnaire-Type",
"code": "SCREENING",
"display": "Screening"
}
],
"item": [
{
"linkId": "GENERAL",
"text": "General",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "GENERALHEAD",
"text": "General",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "COVERLETTER",
"text": "Is the cover letter provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
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"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
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{
"extension": [
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"valueExpression": {
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"expression": "today() + 1 day"
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],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='GENERAL').item.where(linkId='GENERALHEAD').item.where(linkId='COVERLETTER').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "COVERLETTERDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "COVERLETTERNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "COVERLETTERGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
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"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='GENERAL').item.where(linkId='GENERALHEAD').item.where(linkId='COVERLETTER').answer.valueCoding.code='YES'"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "COVERLETTERREFERENCE",
"text": "Does the cover letter references the correct division name \"Health Programs and Delivery Division\" (HPDD)?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
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}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
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"expression": "today() + 1 day"
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],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "COVERLETTERREFERENCEDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
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"expression": "%context.item.where(linkId='GENERAL').item.where(linkId='GENERALHEAD').item.where(linkId='COVERLETTER').answer.valueCoding.code='YES'"
}
}
],
"linkId": "COVERLETTERREFERENCECOVERLETTERNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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"code": "table",
"display": "Group table"
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"text": "Group table"
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"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='GENERAL').item.where(linkId='GENERALHEAD').item.where(linkId='COVERLETTER').answer.valueCoding.code='YES'"
}
}
],
"linkId": "COVERLETTERREFERENCEGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
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"coding": [
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "TABLEOFCONTENTS",
"text": "Is the table of contents provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
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"valueExpression": {
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}
},
{
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"valueExpression": {
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"expression": "today() + 1 day"
}
}
],
"linkId": "TABLEOFCONTENTSDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "TABLEOFCONTENTSNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
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{
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"display": "Group table"
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],
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}
}
],
"linkId": "TABLEOFCONTENTSGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
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"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"coding": [
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "SUBMISSION_SUMMARY",
"text": "Is the Submission Summary Sheet provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
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{
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}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "SUBMISSION_SUMMARY_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "SUBMISSION_SUMMARY_NOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "SUBMISSION_SUMMARYGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "THIRDPARTINVOLVEMENT",
"text": "Is Third Party involvement disclosed appropriately with business arrangement letters, if applicable?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
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{
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}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
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"expression": "today() + 1 day"
}
}
],
"linkId": "THIRDPARTINVOLVEMENTDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "THIRDPARTINVOLVEMENTNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
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}
],
"linkId": "THIRDPARTINVOLVEMENTGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "SUBMISSIONFORMATTING",
"text": "Is the submission formatted and organized appropriately?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='GENERAL').item.where(linkId='GENERALHEAD').item.where(linkId='SUBMISSIONFORMATTING').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "SUBMISSIONFORMATTINGDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "SUBMISSIONFORMATTINGNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "SUBMISSIONFORMATTINGGROUP",
"type": "group",
"repeats": false
}
]
}
]
},
{
"linkId": "PRODUCTDETAILS",
"text": "Product Details and Pricing",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "PRODUCTDETAILSHEAD",
"text": "Product Details and Pricing",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
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},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "PROPOSEDBENEFITPRICE",
"text": "Is the Proposed Drug Benefit Price provided with the correct format?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
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}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='PROPOSEDBENEFITPRICE').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "PROPOSEDBENEFITPRICEDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "PROPOSEDBENEFITPRICENOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "PROPOSEDBENEFITPRICEGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "CROSSREFERENCED",
"text": "Is this product Cross-referenced?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES'"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "BUSINESSAGREEMENTLETTER",
"text": "Are the Business agreement letters from both parties provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES' and %context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='BUSINESSAGREEMENTLETTER').answer.exists()"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "BUSINESSAGREEMENTLETTERDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES'"
}
}
],
"linkId": "BUSINESSAGREEMENTLETTERNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES'"
}
}
],
"linkId": "BUSINESSAGREEMENTLETTERGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES'"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "PRODUCTCONFIRMATIONLETTER",
"text": "Are the Product Confirmation Letters from both parties provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES' and %context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='PRODUCTCONFIRMATIONLETTER').answer.exists()"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "PRODUCTCONFIRMATIONLETTERDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES'"
}
}
],
"linkId": "PRODUCTCONFIRMATIONLETTERNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES'"
}
}
],
"linkId": "PRODUCTCONFIRMATIONLETTERGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES'"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "CONSENTLETTER",
"text": "Are the Consent letters from all parties with information on file with Health Canada provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES' and %context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CONSENTLETTER').answer.exists()"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "CONSENTLETTERDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='PRODUCTDETAILS').item.where(linkId='PRODUCTDETAILSHEAD').item.where(linkId='CROSSREFERENCED').answer.valueCoding.code='YES'"
}
}
],
"linkId": "CONSENTLETTERNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "CONSENTLETTERGROUP",
"type": "group",
"repeats": false
}
]
}
]
},
{
"linkId": "HEALTHCANADADOCUMETANTION",
"text": "Health Canada Documentation",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "HEALTHCANADADOCUMETANTIONHEAD",
"text": "Health Canada Documentation",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "NOTICEOFCOMPLIANCE",
"text": "Is the Notice of Compliance provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "NOTICEOFCOMPLIANCEDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "NOTICEOFCOMPLIANCENOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "NOTICEOFCOMPLIANCEGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "PRODUCTMONOGRAPH",
"text": "Is the Product Monograph provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='PRODUCTMONOGRAPH').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "PRODUCTMONOGRAPHDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "PRODUCTMONOGRAPHNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "PRODUCTMONOGRAPHGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='PRODUCTMONOGRAPH').answer.valueCoding.code='NA'"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "PRODUCTMONOGRAPHSUPPORTINGDOCUMENTS",
"text": "Are the appropriate Supporting Documents provided in place of the Product Monograph?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0",
"item": [
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='PRODUCTMONOGRAPH').answer.valueCoding.code='NA'"
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "help",
"display": "Help-Button"
}
]
}
}
],
"linkId": "PRODUCTMONOGRAPHSUPPORTINGDOCUMENTSHELP",
"text": "<div>List of the appropriate supporting documents:</div><ul><li>Pharmaceutical information.</li><li>Information with respect to the product's clinical pharmacology.</li><li>Information as to the product's indications and clinical use.</li><li>A list of any contra-indications, warnings or precautions in the use of the product and of possible adverse reactions to its use.</li><li>A list of symptoms of an overdose of the product and information as to the treatment of an overdose.</li><li>Information with respect to the dosage and administration of the product.</li><li>Information regarding the availability of dosage forms for each strength of the product marketed in Canada.</li>",
"type": "display"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='PRODUCTMONOGRAPH').answer.valueCoding.code='NA' and %context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='PRODUCTMONOGRAPHSUPPORTINGDOCUMENTS').answer.exists()"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "PRODUCTMONOGRAPHSUPPORTINGDOCUMENTSDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='PRODUCTMONOGRAPH').answer.valueCoding.code='NA'"
}
}
],
"linkId": "PRODUCTMONOGRAPHSUPPORTINGDOCUMENTSNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='PRODUCTMONOGRAPH').answer.valueCoding.code='NA'"
}
}
],
"linkId": "PRODUCTMONOGRAPHSUPPORTINGDOCUMENTSGROUP",
"type": "group",
"repeats": false
}
]
}
]
},
{
"linkId": "ATTESTATIONS",
"text": "Attestations",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "ATTESTATIONSHEAD",
"text": "Attestations",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "CONSENTLETTERATTESTATIONS",
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{
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],
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],
"linkId": "NOPATENTINFRINGEMENTDATE",
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"type": "date",
"required": true
},
{
"linkId": "NOPATENTINFRINGEMENTNOTE",
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"linkId": "COMPARATIVEBIOAVAILABILITYGROUP",
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"display": "Radio Button"
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}
],
"linkId": "BIOEQUIVALENCEDATA",
"text": "Is the Completed Bioequivalence Data checklist provided?",
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"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
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"linkId": "BIOEQUIVALENCEDATADATE",
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"linkId": "BIOEQUIVALENCEDATANOTE",
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}
],
"linkId": "PHARMACOKINETICSTATISTICAL",
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"type": "coding",
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"text": "In the case of Aqueous solutions, are the Physiochemical data and CoAs provided?",
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"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "SCIENTIFICJUSTIFICATIONDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
}
],
"linkId": "SCIENTIFICJUSTIFICATIONNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
}
],
"linkId": "SCIENTIFICJUSTIFICATIONGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "MASTERFORMULATIONFORTHELOT",
"text": "Is the Product master formulation for the lot used in studies provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO' and %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='MASTERFORMULATIONFORTHELOT').answer.exists()"
}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "MASTERFORMULATIONFORTHELOTDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
}
],
"linkId": "MASTERFORMULATIONFORTHELOTNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
}
],
"linkId": "MASTERFORMULATIONFORTHELOTGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "CPID_OR_MASTER_FORMULA",
"text": "Is the CPID or Master Formula provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='CPID_OR_MASTER_FORMULA').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "CPID_OR_MASTER_FORMULA_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "CPID_OR_MASTER_FORMULA_NOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "CPID_OR_MASTER_FORMULAGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "NOT_CONDUCTING_IN-VIVO_BIOEQUIVALENCE",
"text": "Is the Scientific justification for not conducting in-vivo bioequivalence studies provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO' and %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='NOT_CONDUCTING_IN-VIVO_BIOEQUIVALENCE').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "NOT_CONDUCTING_IN-VIVO_BIOEQUIVALENCE_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "NOT_CONDUCTING_IN-VIVO_BIOEQUIVALENCE_NOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "NOT_CONDUCTING_IN-VIVO_BIOEQUIVALENCEGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "SAME_BETWEEN_SUBMITTED_PRODUCT",
"text": "Is the Evidence that the product formulations are the same between submitted product and reference product provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO' and %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='SAME_BETWEEN_SUBMITTED_PRODUCT').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "SAME_BETWEEN_SUBMITTED_PRODUCT_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "SAME_BETWEEN_SUBMITTED_PRODUCT_NOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "SAME_BETWEEN_SUBMITTED_PRODUCTGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "STANDARD_COMPARATIVE_DISSOLUTION",
"text": "Are the Standard comparative dissolution profiles provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO' and %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='STANDARD_COMPARATIVE_DISSOLUTION').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "STANDARD_COMPARATIVE_DISSOLUTION_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "STANDARD_COMPARATIVE_DISSOLUTION_NOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "STANDARD_COMPARATIVE_DISSOLUTIONGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "BCS_BIOWAIVER_TEMPLATE",
"text": "Is the Copy of the manufacturer's completed BCS biowaiver template provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO' and %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='BCS_BIOWAIVER_TEMPLATE').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "BCS_BIOWAIVER_TEMPLATE_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "BCS_BIOWAIVER_TEMPLATE_NOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "BCS_BIOWAIVER_TEMPLATEGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "EVALUATION_REPORT",
"text": "Is the Evaluation report(s) generated by Health Canada provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO' and %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='EVALUATION_REPORT').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "EVALUATION_REPORT_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "EVALUATION_REPORT_NOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
}
],
"linkId": "EVALUATION_REPORTGROUP",
"type": "group",
"repeats": false
}
]
}
]
}
]
}