FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | Screening - Multiple Source for Single Source List.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
{
"resourceType": "Questionnaire",
"id": "6899bb67-ae3f-4869-81c0-59de38f2acc0",
"meta": {
"versionId": "2",
"lastUpdated": "2025-10-15T17:50:48.315+00:00",
"source": "#8c28450ed171c800",
"profile": [
"https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-Questionnaire|1.0.0"
]
},
"version": "3.0.10",
"title": "Multiple Source for Single Source Listing",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"description": "Multiple Source Drug - a drug product manufactured by more than one company or source (generic equivalent)",
"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-FOR-SINGLE",
"display": "Multiple Source for Single Source Listing"
},
{
"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": [
{
"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='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": [
{
"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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"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='GENERAL').item.where(linkId='GENERALHEAD').item.where(linkId='COVERLETTER').answer.valueCoding.code='YES' and %context.item.where(linkId='GENERAL').item.where(linkId='GENERALHEAD').item.where(linkId='COVERLETTERREFERENCE').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": "COVERLETTERREFERENCEDATE",
"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='GENERAL').item.where(linkId='GENERALHEAD').item.where(linkId='COVERLETTER').answer.valueCoding.code='YES'"
}
}
],
"linkId": "COVERLETTERREFERENCECOVERLETTERNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"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'"
}
},
{
"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": "COVERLETTERREFERENCECOVERLETTERGROUP",
"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": "BRAND_REFERENCE_INFORMATION",
"text": "Does the submission include all appropriate Brand Reference Information (DIN, product name, active ingredient(s), dosage form, strength)?",
"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='BRAND_REFERENCE_INFORMATION').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "BRAND_REFERENCE_INFORMATION_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "BRAND_REFERENCE_INFORMATION_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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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "BRAND_REFERENCE_INFORMATION_GROUP",
"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",
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"coding": [
{
"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": [
{
"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='GENERAL').item.where(linkId='GENERALHEAD').item.where(linkId='TABLEOFCONTENTS').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "TABLEOFCONTENTSDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "TABLEOFCONTENTSNOTE",
"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": "TABLEOFCONTENTSGROUP",
"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": "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",
"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='SUBMISSION_SUMMARY').answer.exists()"
}
},
{
"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": [
{
"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": "SUBMISSION_SUMMARY_GROUP",
"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"
},
{
"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='THIRDPARTINVOLVEMENT').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "THIRDPARTINVOLVEMENTDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "THIRDPARTINVOLVEMENTNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"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": "THIRDPARTINVOLVEMENTGROUP",
"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": "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
},
{
"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": "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",
"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": "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"
}
}
],
"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": [
{
"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": "PROPOSEDBENEFITPRICEGROUP",
"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/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": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"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": "CONSENTLETTER",
"text": "Is the Letter of Consent 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='ATTESTATIONS').item.where(linkId='ATTESTATIONSHEAD').item.where(linkId='CONSENTLETTER').answer.exists()"
}
},
{
"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
},
{
"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
},
{
"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": "EVIDENCELETTER",
"text": "Is the Evidence Confirming Ability to Supply Letter 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='ATTESTATIONS').item.where(linkId='ATTESTATIONSHEAD').item.where(linkId='EVIDENCELETTER').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "EVIDENCELETTERDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "EVIDENCELETTERNOTE",
"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": "EVIDENCELETTERGROUP",
"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": "CERTIFICATIONLETTER",
"text": "Is the Certification Confirming that No Rebates Letter 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='ATTESTATIONS').item.where(linkId='ATTESTATIONSHEAD').item.where(linkId='CERTIFICATIONLETTER').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "CERTIFICATIONLETTERDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "CERTIFICATIONLETTERNOTE",
"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": "CERTIFICATIONLETTERGROUP",
"type": "group",
"repeats": false
}
]
}
]
},
{
"linkId": "CLINICALEVIDENCE",
"text": "Evidence/Studies",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "CLINICALEVIDENCEHEAD",
"text": "Evidence/Studies",
"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": "CLINICALDATACHECKLIST",
"text": "Is the Clinical Data Checklist provided, 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"
},
{
"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='CLINICALDATACHECKLIST').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "CLINICALDATACHECKLISTDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "CLINICALDATACHECKLISTNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "CLINICALDATACHECKLISTGROUP",
"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": "PIVOTAL_CLINICAL_TRIALS",
"text": "Are the published pivotal clinical trials for the 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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='PIVOTAL_CLINICAL_TRIALS').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "PIVOTAL_CLINICAL_TRIALS_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "PIVOTAL_CLINICAL_TRIALS_NOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
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{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "PIVOTAL_CLINICAL_TRIALS_GROUP",
"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": "EVIDENCE_OF_BIOEQUIVALENCE",
"text": "Is evidence of bioequivalence with the 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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='EVIDENCE_OF_BIOEQUIVALENCE').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "EVIDENCE_OF_BIOEQUIVALENCE_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "EVIDENCE_OF_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"
}
}
],
"linkId": "EVIDENCE_OF_BIOEQUIVALENCE_GROUP",
"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": "COMPARATIVEBIOAVAILABILITY",
"text": "Are the appropriate Comparative Bioavailability 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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "COMPARATIVEBIOAVAILABILITYDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "COMPARATIVEBIOAVAILABILITYNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "COMPARATIVEBIOAVAILABILITYGROUP",
"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.exists().not() or %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": "BIOEQUIVALENCEDATA",
"text": "Is the Completed Bioequivalence Data checklist 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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"valueExpression": {
"language": "text/fhirpath",
"expression": "(%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.exists().not() or %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='BIOEQUIVALENCEDATA').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": "BIOEQUIVALENCEDATADATE",
"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.exists().not() or %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code!='NO'"
}
}
],
"linkId": "BIOEQUIVALENCEDATANOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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"valueExpression": {
"language": "text/fhirpath",
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}
},
{
"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": "BIOEQUIVALENCEDATAGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
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"valueExpression": {
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"expression": "%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.exists().not() or %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": "PHARMACOKINETICSTATISTICAL",
"text": "Is the Completed Pharmacokinetic/Statistical Worksheet 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.exists().not() or %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='PHARMACOKINETICSTATISTICAL').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": "PHARMACOKINETICSTATISTICALDATE",
"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.exists().not() or %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code!='NO'"
}
}
],
"linkId": "PHARMACOKINETICSTATISTICALNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
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},
{
"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": "PHARMACOKINETICSTATISTICALGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
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"valueExpression": {
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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",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "MASTERFORMULATION",
"text": "Is the Product master formulation for the biolot 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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"valueExpression": {
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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": {
"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-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "MASTERFORMULATIONDATE",
"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.exists().not() or %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code!='NO'"
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}
],
"linkId": "MASTERFORMULATIONNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
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}
},
{
"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": "MASTERFORMULATIONGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
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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"
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"valueCodeableConcept": {
"coding": [
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"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "PHARMACODYNAMICSTUDIES",
"text": "Are the Pharmacodynamic studies provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
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},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
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"valueExpression": {
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"expression": "today() + 1 day"
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},
{
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"valueExpression": {
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}
],
"linkId": "PHARMACODYNAMICSTUDIESDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"extension": [
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"valueExpression": {
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}
],
"linkId": "PHARMACODYNAMICSTUDIESNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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"valueExpression": {
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"expression": "%context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
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},
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"text": "Group table"
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],
"linkId": "PHARMACODYNAMICSTUDIESGROUP",
"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"
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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",
"valueCodeableConcept": {
"coding": [
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"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "PHYSIOCHEMICALDATA",
"text": "In the case of Aqueous solutions, are the Physiochemical data and CoAs provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
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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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"url": "http://hl7.org/fhir/StructureDefinition/maxValue"
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],
"linkId": "PHYSIOCHEMICALDATADATE",
"text": "Date",
"type": "date",
"required": true
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{
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}
],
"linkId": "PHYSIOCHEMICALDATANOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
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{
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"linkId": "PHYSIOCHEMICALDATAGROUP",
"type": "group",
"repeats": false
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{
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"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",
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"code": "radio-button",
"display": "Radio Button"
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"text": "Radio Button"
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],
"linkId": "SCIENTIFICJUSTIFICATION",
"text": "In the case of non-systemic effect drug products, are the following provided: scientific justification for in-vitro studies, evidence that product formulations are qualitatively and quantitatively the same between the submitted products and reference products, comparative dissolution profiles, evidence of formulation proportionality?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
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},
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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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{
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],
"linkId": "SCIENTIFICJUSTIFICATIONDATE",
"text": "Date",
"type": "date",
"required": true
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{
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],
"linkId": "SCIENTIFICJUSTIFICATIONNOTE",
"text": "Note",
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"required": false,
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"linkId": "SCIENTIFICJUSTIFICATIONGROUP",
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"repeats": false
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{
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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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"display": "Radio Button"
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],
"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"
},
{
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}
},
{
"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"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-initialExpression",
"valueExpression": {
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"expression": "today() + 1 day"
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}
],
"linkId": "MASTERFORMULATIONFORTHELOTDATE",
"text": "Date",
"type": "date",
"required": true
},
{
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}
],
"linkId": "MASTERFORMULATIONFORTHELOTNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
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{
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"linkId": "MASTERFORMULATIONFORTHELOTGROUP",
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{
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],
"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": [
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
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{
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
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"expression": "today() + 1 day"
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],
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},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
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}
},
{
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"valueExpression": {
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"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
},
{
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"linkId": "CPID_OR_MASTER_FORMULA_GROUP",
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"repeats": false
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]
}
]
},
{
"linkId": "FINANCIALIMPACT",
"text": "Financial Impact Analysis",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
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}
],
"linkId": "BIAREPORT",
"text": "Is the BIA Report provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
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{
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},
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}
],
"linkId": "BIAREPORTDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "BIAREPORTNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
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],
"linkId": "BIAREPORTGROUP",
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{
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],
"text": "Radio Button"
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}
],
"linkId": "BIAMODEL",
"text": "Is the BIA model provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
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},
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}
],
"linkId": "BIAMODELDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "BIAMODELNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
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{
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