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Packageca.on.health.idms.agreementmvp
Resource TypeQuestionnaire
IdExternal-NutrLstChg.json
FHIR VersionR5

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Source1

{
  "resourceType": "Questionnaire",
  "id": "cdbc9a5a-8352-4e7c-8d6f-92e4ac26a523",
  "meta": {
    "versionId": "5",
    "lastUpdated": "2026-02-03T16:27:22.104+00:00",
    "source": "#b8ff2a1f9758faf2",
    "profile": [
      "https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-Questionnaire|1.0.0"
    ]
  },
  "extension": [
    {
      "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Questionnaire-External-Indicator",
      "valueBoolean": true
    }
  ],
  "version": "3.0.10",
  "title": "NutrListChg",
  "status": "active",
  "experimental": false,
  "publisher": "DIRECT",
  "purpose": "https://files.ontario.ca/moh-drug-submission-ontario-guidelines-nutrition-products-2023-08-30.pdf",
  "code": [
    {
      "code": "SUB-NUTRITIONAL-PRODUCT-NAME",
      "display": "Product Name Change"
    },
    {
      "system": "https://health.gov.on.ca/idms/fhir/CodeSystem/Questionnaire-Type",
      "code": "SUBMIT",
      "display": "Submit "
    }
  ],
  "item": [
    {
      "linkId": "CHANGEDETAILSNAV",
      "text": "Change Details",
      "type": "group",
      "required": false,
      "repeats": false,
      "readOnly": false,
      "item": [
        {
          "linkId": "CHANGEDETAILSGROUP",
          "text": "Change Details",
          "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-KIND-OF"
                }
              ],
              "linkId": "CURRENTVALUE",
              "definition": "https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-ServiceRequest-New#ServiceRequest.extension.where(url='https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Indication').valueString",
              "text": "Value as it currently appears",
              "type": "text",
              "required": true,
              "maxLength": 100
            },
            {
              "extension": [
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "NEWVALUE",
              "definition": "https://health.gov.on.ca/idms/fhir/StructureDefinition/IDMS-ServiceRequest-New#ServiceRequest.extension.where(url='https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Indication').valueString",
              "text": "New Value",
              "type": "text",
              "required": true,
              "maxLength": 100
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.ms-excel"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/msword"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/pdf"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                  "valueDecimal": 10
                },
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "CHANGERATIONALEDOC",
              "text": "Rationale for the change(s)",
              "type": "attachment",
              "required": true,
              "repeats": false
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.ms-excel"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/msword"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/pdf"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                  "valueDecimal": 10
                },
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "OLDPRODUCTLABELDOC",
              "text": "Old product label for sale in the Canadian market",
              "type": "attachment",
              "required": true,
              "repeats": false
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.ms-excel"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/msword"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/pdf"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                  "valueDecimal": 10
                },
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "NEWPRODUCTLABELDOC",
              "text": "New product label for sale in the Canadian market",
              "type": "attachment",
              "required": true,
              "repeats": false
            },
            {
              "extension": [
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "EFFECTIVECHANGEDATE",
              "text": "Effective date for the change(s)",
              "type": "date",
              "required": true,
              "item": [
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "help",
                            "display": "Help-Button"
                          }
                        ],
                        "text": "Help-Button"
                      }
                    }
                  ],
                  "linkId": "EFFECTIVECHANGEDATEHELP",
                  "text": "If no specific date is available, please specify the expected target date for the change.",
                  "type": "display"
                }
              ]
            },
            {
              "extension": [
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "DISCONTINUEDDATE",
              "text": "Date the currently listed product will be discontinued and removed from the market",
              "type": "date",
              "required": true
            },
            {
              "extension": [
                {
                  "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                  "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                }
              ],
              "linkId": "EXPIRYDATE",
              "text": "Expiry date of the last lot of the currently listed product",
              "type": "date",
              "required": true
            },
            {
              "linkId": "FORMULATIONINFORMAITONGROUP",
              "text": "Formulation Information",
              "type": "group",
              "item": [
                {
                  "extension": [
                    {
                      "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                      "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                    }
                  ],
                  "linkId": "FORMULATIONCHANGE",
                  "text": "Has there been a change to formulation?",
                  "type": "boolean",
                  "required": true,
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "FORMULATIONCHANGEHELP",
                      "text": "If formulation has changed i.e. the product efficacy, tolerance and/or safety are altered, the ministry requires the old and new quantitative formula, and nutrient formulation with the differences highlighted.",
                      "type": "display"
                    }
                  ]
                },
                {
                  "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-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "check-box",
                            "display": "Check box"
                          }
                        ],
                        "text": "Check box"
                      }
                    }
                  ],
                  "linkId": "CONFIRMNOFORMULATIONCHANGE",
                  "text": "I confirm that formulation has not changed.",
                  "type": "boolean",
                  "enableWhen": [
                    {
                      "question": "FORMULATIONCHANGE",
                      "operator": "=",
                      "answerBoolean": false
                    }
                  ],
                  "required": true
                },
                {
                  "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-itemControl",
                      "valueCodeableConcept": {
                        "coding": [
                          {
                            "system": "http://hl7.org/fhir/questionnaire-item-control",
                            "code": "check-box",
                            "display": "Check box"
                          }
                        ],
                        "text": "Check box"
                      }
                    }
                  ],
                  "linkId": "CONFIRMNOCLINICALIMPACT",
                  "text": "I confirm that clinical response or product safety have not been impacted.",
                  "type": "boolean",
                  "enableWhen": [
                    {
                      "question": "FORMULATIONCHANGE",
                      "operator": "=",
                      "answerBoolean": false
                    }
                  ],
                  "required": true
                },
                {
                  "extension": [
                    {
                      "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                      "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                    }
                  ],
                  "linkId": "CLINICALRESPONSECHANGE",
                  "text": "Does the change impact clinical response or product safety?",
                  "type": "boolean",
                  "enableWhen": [
                    {
                      "question": "FORMULATIONCHANGE",
                      "operator": "=",
                      "answerBoolean": true
                    }
                  ],
                  "required": true
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.ms-excel"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/msword"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/pdf"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                      "valueDecimal": 10
                    },
                    {
                      "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                      "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                    }
                  ],
                  "linkId": "NOTALTEREDEVIDENCE",
                  "text": "Evidence that the product efficacy, tolerance and/or safety are not altered",
                  "type": "attachment",
                  "enableWhen": [
                    {
                      "question": "CLINICALRESPONSECHANGE",
                      "operator": "=",
                      "answerBoolean": false
                    }
                  ],
                  "required": true,
                  "repeats": false
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.ms-excel"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/msword"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/pdf"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                      "valueDecimal": 10
                    },
                    {
                      "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                      "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                    }
                  ],
                  "linkId": "OLDNEWFORMULADOC",
                  "text": "Documentation with respect to the old and new quantitative formula, and nutrient formulation with the differences highlighted",
                  "type": "attachment",
                  "enableWhen": [
                    {
                      "question": "CLINICALRESPONSECHANGE",
                      "operator": "=",
                      "answerBoolean": true
                    }
                  ],
                  "required": true,
                  "repeats": false
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.ms-excel"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/msword"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/pdf"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                      "valueDecimal": 10
                    },
                    {
                      "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                      "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                    }
                  ],
                  "linkId": "PRODUCTSPECIFICSTUDIES",
                  "text": "Product specific clinical studies for the new formulation",
                  "type": "attachment",
                  "enableWhen": [
                    {
                      "question": "CLINICALRESPONSECHANGE",
                      "operator": "=",
                      "answerBoolean": true
                    }
                  ],
                  "required": true,
                  "repeats": false
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.ms-excel"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/msword"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/pdf"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                      "valueDecimal": 10
                    },
                    {
                      "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                      "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                    }
                  ],
                  "linkId": "NUTRITIONPRODUCTWORKSHEET",
                  "text": "Nutrition Product Worksheet",
                  "type": "attachment",
                  "enableWhen": [
                    {
                      "question": "CLINICALRESPONSECHANGE",
                      "operator": "=",
                      "answerBoolean": true
                    }
                  ],
                  "required": true,
                  "repeats": false,
                  "item": [
                    {
                      "extension": [
                        {
                          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept": {
                            "coding": [
                              {
                                "system": "http://hl7.org/fhir/questionnaire-item-control",
                                "code": "help",
                                "display": "Help-Button"
                              }
                            ],
                            "text": "Help-Button"
                          }
                        }
                      ],
                      "linkId": "NUTRITIONPRODUCTWORKSHEETHELP",
                      "text": "Please refer to the Drug Submissions website for the most recent template.",
                      "type": "display"
                    }
                  ]
                },
                {
                  "extension": [
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.ms-excel"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/msword"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                      "valueCode": "application/pdf"
                    },
                    {
                      "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                      "valueDecimal": 10
                    },
                    {
                      "url": "https://health.gov.on.ca/idms/fhir/StructureDefinition/Extension-Question-Required-Level",
                      "valueCode": "QUESTIONNAIRE-REQUIRED-LEVEL-KIND-OF"
                    }
                  ],
                  "linkId": "SUPPORTINGSTUDYINFORMATION",
                  "text": "Supporting information or study listed for the Nutrition Product Work Sheet ",
                  "type": "attachment",
                  "enableWhen": [
                    {
                      "question": "CLINICALRESPONSECHANGE",
                      "operator": "=",
                      "answerBoolean": true
                    }
                  ],
                  "required": true,
                  "repeats": true,
                  "readOnly": false
                }
              ]
            }
          ]
        }
      ]
    },
    {
      "linkId": "SUPPLEMENTALNAV",
      "text": "Supplemental Information",
      "type": "group",
      "required": false,
      "repeats": false,
      "readOnly": false,
      "item": [
        {
          "linkId": "SUPPLEMENTALGROUP",
          "text": "Supplemental Information",
          "type": "group",
          "required": false,
          "repeats": false,
          "readOnly": false,
          "item": [
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept": {
                    "coding": [
                      {
                        "system": "http://hl7.org/fhir/questionnaire-item-control",
                        "code": "help",
                        "display": "Help-Button"
                      }
                    ],
                    "text": "Help-Button"
                  }
                }
              ],
              "linkId": "SUPPLEMENTALGROUPHELP",
              "text": "Please provide any additional information and/or materials that may aid the ministry in assessing your submission. (e.g., Health Canada evaluation reports).",
              "type": "display"
            },
            {
              "extension": [
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.ms-excel"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.spreadsheetml.sheet"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/msword"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/vnd.openxmlformats-officedocument.wordprocessingml.document"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/mimeType",
                  "valueCode": "application/pdf"
                },
                {
                  "url": "http://hl7.org/fhir/StructureDefinition/maxSize",
                  "valueDecimal": 10
                }
              ],
              "linkId": "SUPPLEMENTALSUPPORTING",
              "text": "Supporting Documents",
              "type": "attachment",
              "required": false,
              "repeats": true,
              "readOnly": false
            },
            {
              "linkId": "SUPPLEMENTALADDITIONALINFO",
              "text": "Additional Information",
              "type": "text",
              "required": false,
              "maxLength": 1000
            }
          ]
        }
      ]
    }
  ]
}