FHIR IG analytics| Package | ca.on.health.idms.agreementmvp |
| Resource Type | Questionnaire |
| Id | Screening - Biosim Line Ext.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
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"meta": {
"versionId": "1",
"lastUpdated": "2024-07-26T15:17:01.020+00:00",
"source": "#smileutil-66cbd3",
"profile": [
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"version": "3.0.10",
"title": "Biosim Line Ext",
"status": "active",
"experimental": false,
"publisher": "DIRECT",
"description": "A biologic drug that is highly similar to a biologic drug that was already authorized for sale (known as the reference biologic drug). Biosimilars are not generics since they are not identical to the reference biologic drug due to complex manufacturing procedures. Biosimilar drugs are tested to ensure their safety and efficacy as the innovator drug and are usually less expensive.",
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},
{
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"code": "SUB-BIOSIMILAR-LINE",
"display": "Biosimilar Line Extension"
},
{
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"code": "SCREENING",
"display": "Screening"
}
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"repeats": false,
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"item": [
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"text": "Is the table of contents provided?",
"type": "coding",
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"linkId": "THIRDPARTINVOLVEMENT",
"text": "Is Third Party involvement disclosed appropriately with business arrangement letters, if applicable?",
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{
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{
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],
"linkId": "PRODUCTMONOGRAPH",
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"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='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
}
]
}
]
},
{
"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",
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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": [
{
"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": [
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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-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": {
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{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
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],
"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"
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{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "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
},
{
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"code": "table",
"display": "Group table"
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}
}
],
"linkId": "EVIDENCELETTERGROUP",
"type": "group",
"repeats": false
},
{
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"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
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{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "horizontal"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
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{
"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": [
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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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}
],
"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()"
}
},
{
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"valueExpression": {
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"expression": "today() + 1 day"
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}
],
"linkId": "CERTIFICATIONLETTERDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "CERTIFICATIONLETTERNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
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"code": "table",
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],
"text": "Group table"
}
}
],
"linkId": "CERTIFICATIONLETTERGROUP",
"type": "group",
"repeats": false
}
]
}
]
},
{
"linkId": "CLINICALEVIDENCE",
"text": "Evidence/Studies",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
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"linkId": "CLINICALEVIDENCEHEAD",
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"required": false,
"repeats": false,
"readOnly": false,
"item": [
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"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "JUSTIFICATIONFORTHERAPEUTIC",
"text": "Is the Justification for the therapeutic need for the new strength/format 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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{
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}
],
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},
{
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},
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}
}
],
"linkId": "JUSTIFICATIONFORTHERAPEUTICDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "JUSTIFICATIONFORTHERAPEUTICNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
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],
"linkId": "JUSTIFICATIONFORTHERAPEUTICGROUP",
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"repeats": false
},
{
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{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "radio-button",
"display": "Radio Button"
}
],
"text": "Radio Button"
}
}
],
"linkId": "CPIDORMASTERFORMULATION",
"text": "Is the CPID or master formulation as evidence of formulation proportionality for the submitted strength/format 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='CLINICALEVIDENCE').item.where(linkId='CLINICALEVIDENCEHEAD').item.where(linkId='CPIDORMASTERFORMULATION').answer.exists()"
}
},
{
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"valueExpression": {
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"expression": "today() + 1 day"
}
}
],
"linkId": "CPIDORMASTERFORMULATIONDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "CPIDORMASTERFORMULATIONNOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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{
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],
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}
}
],
"linkId": "CPIDORMASTERFORMULATIONGROUP",
"type": "group",
"repeats": false
},
{
"extension": [
{
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{
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
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},
{
"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": "SCIENTIFICEVIDENCE",
"text": "Is the scientific evidence upon which Health Canada approved the biosimilar line extension drug product for sale in Canada provided?",
"type": "coding",
"required": true,
"answerValueSet": "https://health.gov.on.ca/idms/fhir/ValueSet/Form-Yes-No-NA|1.0.0"
},
{
"extension": [
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"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"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",
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}
},
{
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"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "SCIENTIFICEVIDENCEDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "SCIENTIFICEVIDENCENOTE",
"text": "Note",
"type": "text",
"required": false,
"maxLength": 1000
},
{
"extension": [
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"coding": [
{
"system": "http://hl7.org/fhir/questionnaire-item-control",
"code": "table",
"display": "Group table"
}
],
"text": "Group table"
}
}
],
"linkId": "SCIENTIFICEVIDENCEGROUP",
"type": "group",
"repeats": false
}
]
}
]
},
{
"linkId": "FINANCIALIMPACT",
"text": "Financial Impact Analysis",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
{
"linkId": "FINANCIALIMPACTHEAD",
"text": "Financial Impact Analysis",
"type": "group",
"required": false,
"repeats": false,
"readOnly": false,
"item": [
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"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
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},
{
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"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": "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"
},
{
"extension": [
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"url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
"valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-REQUIRED"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-calculatedValue",
"valueExpression": {
"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='FINANCIALIMPACT').item.where(linkId='FINANCIALIMPACTHEAD').item.where(linkId='BIAREPORT').answer.exists()"
}
},
{
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"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "BIAREPORTDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "BIAREPORTNOTE",
"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": "BIAREPORTGROUP",
"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": "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"
},
{
"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='FINANCIALIMPACT').item.where(linkId='FINANCIALIMPACTHEAD').item.where(linkId='BIAMODEL').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "BIAMODELDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "BIAMODELNOTE",
"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": "BIAMODELGROUP",
"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": "FINANCIALIMPACTSTUDY",
"text": "Is the OPDP Financial Impact Analysis 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='FINANCIALIMPACT').item.where(linkId='FINANCIALIMPACTHEAD').item.where(linkId='FINANCIALIMPACTSTUDY').answer.exists()"
}
},
{
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "today() + 1 day"
}
}
],
"linkId": "FINANCIALIMPACTSTUDYDATE",
"text": "Date",
"type": "date",
"required": true
},
{
"linkId": "FINANCIALIMPACTSTUDYNOTE",
"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": "FINANCIALIMPACTSTUDYGROUP",
"type": "group",
"repeats": false
}
]
}
]
}
]
}