FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | Screening - Natural Health Prodcut.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
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"meta": {
"versionId": "1",
"lastUpdated": "2024-07-26T15:17:03.300+00:00",
"source": "#smileutil-cf5bd9",
"profile": [
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"version": "3.0.10",
"title": "Natural Health Product",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"description": "Natural Health Product",
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{
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"code": "SUB-NEW-NATURAL",
"display": "New Natural Health Product"
},
{
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"code": "SCREENING",
"display": "Screening"
}
],
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"text": "General",
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"required": false,
"repeats": false,
"readOnly": false,
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"text": "Is the cover letter provided?",
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"required": true,
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{
"linkId": "HEALTHCANADADOCUMETANTION",
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"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "PLA_FORM",
"text": "Is a copy of the completed, dated and signed Product Licence Application Form (PLA-Form) approved 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": "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='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='PLA_FORM').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": "PLA_FORM_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": "PLA_FORM_NOTE",
"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='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
},
{
"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": "PLA_FORM_GROUP",
"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='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
},
{
"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'"
}
},
{
"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": "PRODUCT_LICENSE",
"text": "Is a Product License with Product Number issued by HC 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='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO' and %context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='PRODUCT_LICENSE').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": "PRODUCT_LICENSE_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": "PRODUCT_LICENSE_NOTE",
"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='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
},
{
"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": "PRODUCT_LICENSE_GROUP",
"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='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
},
{
"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'"
}
},
{
"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": "SITE_LICENSE",
"text": "Is a Copy of the Site License 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='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO' and %context.item.where(linkId='HEALTHCANADADOCUMETANTION').item.where(linkId='HEALTHCANADADOCUMETANTIONHEAD').item.where(linkId='SITE_LICENSE').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": "SITE_LICENSE_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": "SITE_LICENSE_NOTE",
"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='NOTICEOFCOMPLIANCE').answer.valueCoding.code='NO'"
}
},
{
"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": "SITE_LICENSE_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": "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-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
},
{
"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()"
}
}
],
"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-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
},
{
"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()"
}
}
],
"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-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
},
{
"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()"
}
}
],
"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-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
},
{
"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()"
}
}
],
"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
},
{
"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": "NO_PATENT_INFRINGEMENT_LETTER",
"text": "Is the Letter confirming no patent infringement 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-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
},
{
"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='NO_PATENT_INFRINGEMENT_LETTER').answer.exists()"
}
}
],
"linkId": "NO_PATENT_INFRINGEMENT_LETTER_DATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "NO_PATENT_INFRINGEMENT_LETTER_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": "NO_PATENT_INFRINGEMENT_LETTER_GROUP",
"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": "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-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
},
{
"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()"
}
}
],
"linkId": "COMPARATIVEBIOAVAILABILITYDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "COMPARATIVEBIOAVAILABILITYNOTE",
"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": "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.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": "PHARMACODYNAMIC_STUDIES",
"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"
},
{
"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='PHARMACODYNAMIC_STUDIES').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": "PHARMACODYNAMIC_STUDIES_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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
}
],
"linkId": "PHARMACODYNAMIC_STUDIES_NOTE",
"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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
},
{
"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": "PHARMACODYNAMIC_STUDIES_GROUP",
"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": "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"
},
{
"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='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='PHYSIOCHEMICALDATA').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": "PHYSIOCHEMICALDATADATE",
"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": "PHYSIOCHEMICALDATANOTE",
"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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
},
{
"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": "PHYSIOCHEMICALDATAGROUP",
"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": "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"
},
{
"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.code='NO' and %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='SCIENTIFICJUSTIFICATION').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": "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/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": "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": "SCIENTIFICJUSTIFICATIONGROUP",
"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"
},
{
"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": "BIOEQUIVALENCE_DATA",
"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": [
{
"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='BIOEQUIVALENCE_DATA').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": "BIOEQUIVALENCE_DATA_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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
}
],
"linkId": "BIOEQUIVALENCE_DATA_NOTE",
"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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
},
{
"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": "BIOEQUIVALENCE_DATA_GROUP",
"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": "PHARMACOKINETIC_STATISTICAL",
"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.code='NO' and %context.item.where(linkId='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='PHARMACOKINETIC_STATISTICAL').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": "PHARMACOKINETIC_STATISTICAL_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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
}
],
"linkId": "PHARMACOKINETIC_STATISTICAL_NOTE",
"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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='COMPARATIVEBIOAVAILABILITY').answer.valueCoding.code='NO'"
}
},
{
"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": "PHARMACOKINETIC_STATISTICAL_GROUP",
"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/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": "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": "MASTERFORMULATIONFORTHELOTGROUP",
"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": "MASTER_FORMULATION_FOR_BIOLOT",
"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": [
{
"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='MASTER_FORMULATION_FOR_BIOLOT').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": "MASTER_FORMULATION_FOR_BIOLOT_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='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": "MASTER_FORMULATION_FOR_BIOLOT_NOTE",
"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='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": "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": "MASTER_FORMULATION_FOR_BIOLOT_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": "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-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
},
{
"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()"
}
}
],
"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_FORMULA_GROUP",
"type": "group",
"repeats": false
}
]
}
]
}
]
}