{
"description": null,
"_filename": "IDMS-QUESTIONNAIRE-EXAMPLE.json",
"package_name": "ca.on.health.idms",
"subjectType": [ "Organization" ],
"date": null,
"meta": {
"source": "#EJMr1gddVQ4OWEMF",
"versionId": "10",
"lastUpdated": "2023-09-07T13:23:36.342+00:00"
},
"publisher": "IDMS",
"name": null,
"item": [ {
"item": [ {
"item": [ {
"item": [ {
"linkId": "DIN",
"repeats": false,
"item": [ {
"text": "Must be 8 digits",
"type": "display",
"linkId": "DINHELP",
"repeats": false,
"readOnly": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"type": "string",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/minLength",
"valueInteger": 8
}, {
"url": "http://hl7.org/fhir/StructureDefinition/regex",
"valueString": "[0-9]*"
} ],
"readOnly": false,
"maxLength": 8,
"required": true,
"text": "DIN"
}, {
"item": [ {
"text": "Strength",
"type": "integer",
"linkId": "STRENGTH1",
"repeats": false,
"readOnly": false,
"required": true
}, {
"text": "Dosage Form",
"type": "string",
"linkId": "DOS2",
"repeats": false,
"readOnly": false,
"required": true,
"maxLength": 100
} ],
"type": "group",
"linkId": "STREGHTDOSHORIZONTAL",
"repeats": false,
"readOnly": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group gtable"
} ]
}
} ]
}, {
"item": [ {
"text": "Package type",
"type": "coding",
"linkId": "PACKTYPE1",
"repeats": false,
"readOnly": false,
"required": false,
"answerOption": [ {
"valueCoding": {
"code": "TABLET",
"display": "Tablet"
}
}, {
"valueCoding": {
"code": "ML",
"display": "ml"
}
}, {
"valueCoding": {
"code": "MG",
"display": "mg"
}
} ]
}, {
"text": "Package size",
"type": "string",
"linkId": "PACKAGESIZE",
"repeats": false,
"readOnly": false,
"required": false,
"maxLength": 50
} ],
"type": "group",
"linkId": "PACKTYPESIZEHORIZONTAL",
"repeats": false,
"readOnly": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group gtable"
} ]
}
} ]
}, {
"item": [ {
"text": "Proposed Drug Benefit Price per smallest unit",
"type": "decimal",
"linkId": "DBPRICE1",
"repeats": false,
"readOnly": false,
"required": true
}, {
"text": "Proposed Drug Benefit Price per smallest dispensable unit for each package size",
"type": "decimal",
"linkId": "SMALLSIZE1",
"repeats": false,
"readOnly": false,
"required": true
} ],
"type": "group",
"linkId": "PRICEHORIZONTAL",
"repeats": false,
"readOnly": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group gtable",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group gtable"
} ]
}
} ]
}, {
"text": "DIN",
"type": "display",
"linkId": "GROUPHELP",
"repeats": false,
"readOnly": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Enter drug information",
"type": "group",
"linkId": "DOSGROUPMULTI",
"repeats": true,
"readOnly": false,
"required": false
} ],
"text": "Dosage",
"type": "group",
"linkId": "DOSINFO",
"repeats": false,
"readOnly": false,
"required": false
} ],
"text": "Dosage",
"type": "group",
"linkId": "DOSAGTAB",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"item": [ {
"text": "Some general info about uploading docs.",
"type": "display",
"linkId": "testdisplay1",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-displayCategory",
"valueCode": "display-success"
} ]
}, {
"text": "Cover Letter",
"type": "attachment",
"linkId": "COVLET",
"repeats": true,
"readOnly": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}, {
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
} ]
}, {
"text": "Additional Notes about the cover letter",
"type": "text",
"linkId": "COVLETNOTES",
"repeats": false,
"readOnly": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-enableWhenExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%context.item.where(linkId='DOCGROUP').item.where(linkId='GEN').item.where(linkId='COVLET').item.empty().not()"
}
} ],
"maxLength": 2000
} ],
"text": "General Documentation",
"type": "group",
"linkId": "GEN",
"repeats": false,
"readOnly": false,
"required": false
} ],
"text": "General Documentation",
"type": "group",
"linkId": "DOCGROUP",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"item": [ {
"text": "Some general info about uploading docs.",
"type": "display",
"linkId": "testdisplay1",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-displayCategory",
"valueCode": "display-success"
} ]
}, {
"item": [ {
"text": "Document Notes",
"type": "text",
"linkId": "COMPDOCNOTES",
"repeats": false,
"readOnly": false,
"required": false,
"maxLength": 2000
} ],
"text": "Notice of Compliance",
"type": "attachment",
"linkId": "NOTCOMP",
"repeats": true,
"readOnly": false,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
} ]
}, {
"text": "Do you have any Product Monograph for this submission?",
"type": "boolean",
"linkId": "PRODMONBOOL",
"repeats": false,
"readOnly": false,
"required": true
}, {
"text": "Product Monograph",
"type": "attachment",
"linkId": "ATT",
"repeats": false,
"readOnly": false,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}, {
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
} ],
"enableWhen": [ {
"operator": "=",
"question": "PRODMONBOOL",
"answerBoolean": true
} ]
}, {
"text": "Pharmaceutical information",
"type": "attachment",
"linkId": "ATTPHAR",
"repeats": false,
"readOnly": false,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}, {
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
} ],
"enableWhen": [ {
"operator": "=",
"question": "PRODMONBOOL",
"answerBoolean": false
} ]
}, {
"text": " Information with respect to the product’s clinical pharmacology",
"type": "attachment",
"linkId": "ATTPHARM",
"repeats": false,
"readOnly": false,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}, {
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
} ],
"enableWhen": [ {
"operator": "=",
"question": "PRODMONBOOL",
"answerBoolean": false
} ]
}, {
"text": "Information as to the product’s indications and clinical use",
"type": "attachment",
"linkId": "ATTCLIN",
"repeats": false,
"readOnly": false,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
} ],
"enableWhen": [ {
"operator": "=",
"question": "PRODMONBOOL",
"answerBoolean": false
} ]
}, {
"text": "Letter of Consent",
"type": "attachment",
"linkId": "CONSENTLETTER",
"repeats": false,
"readOnly": false,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
} ]
}, {
"text": "Letter Confirming Ability To Supply",
"type": "attachment",
"linkId": "SUPPLYLETTER",
"repeats": false,
"readOnly": false,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
} ]
} ],
"text": "Health Canada Documentation",
"type": "group",
"linkId": "HCANADA",
"repeats": false,
"readOnly": false,
"required": false
} ],
"text": "Health Canada Documentation",
"type": "group",
"linkId": "HCDOCGROUP",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"item": [ {
"text": "Do you have any business agreements with any third-party with respect to the drug product?",
"type": "boolean",
"linkId": "BOOLBUSAGREEMENTS",
"repeats": false,
"readOnly": false,
"required": true
}, {
"item": [ {
"text": "Third-party name",
"type": "string",
"linkId": "THIRDPARTYNAME",
"repeats": false,
"readOnly": false,
"required": true,
"maxLength": 100
}, {
"text": "Third-party type",
"type": "coding",
"linkId": "THIRDPARTYTYPE",
"repeats": false,
"readOnly": false,
"required": true,
"answerOption": [ {
"valueCoding": {
"code": "CONSULTANT",
"display": "Consultant"
}
}, {
"valueCoding": {
"code": "CROSSLIC",
"display": "Cross-licenced"
}
}, {
"valueCoding": {
"code": "COMARK",
"display": "Co-marketing"
}
}, {
"valueCoding": {
"code": "OTHER",
"display": "Other"
}
} ]
}, {
"text": "Product Confirmation Letter from Third-party ",
"type": "attachment",
"linkId": "CONFIRMATIONLETTER",
"repeats": false,
"readOnly": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
} ]
}, {
"text": "Product Confirmation Letter from NOC holder",
"type": "attachment",
"linkId": "CONFIRMATIONNOC",
"repeats": false,
"readOnly": false,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/maxSize",
"valueDecimal": 10
}, {
"url": "http://hl7.org/fhir/StructureDefinition/mimeType",
"valueCode": "application/pdf"
} ]
} ],
"text": "Agreements",
"type": "group",
"linkId": "THIRDPARTYGROUP",
"repeats": true,
"readOnly": false,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "BOOLBUSAGREEMENTS",
"answerBoolean": true
} ]
} ],
"text": "Third-party agreement",
"type": "group",
"linkId": "THIRDPARTY",
"repeats": false,
"readOnly": false,
"required": false
} ],
"text": "Third-party agreement",
"type": "group",
"linkId": "THIRDPARTYTOP",
"repeats": false,
"readOnly": false,
"required": false
} ],
"type": null,
"experimental": "false",
"resourceType": "Questionnaire",
"title": "New generic drug product",
"package_version": "1.0.2-beta",
"status": "active",
"id": "5d4b5d92-4d37-419a-b91e-be11f64fee96",
"kind": null,
"url": "http://health.gov.on.ca/idms/fhir/Questionnaire/SUB-GENERIC-PRODUCT/Version1",
"code": [ {
"code": "PRODUCT-MULTI-SOURCE",
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Internal-Product-Types",
"display": "Multi source drug product streamlined or Multi source drug product non- streamlined"
}, {
"code": "SUB-GENERIC-PRODUCT",
"system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Internal-Submission-Types",
"display": "New generic drug product"
} ],
"identifier": [ {
"use": "official",
"value": "SUB-GENERIC-PRODUCT"
} ],
"version": null
}