A guide to the new disaggregated data questionnaire for drug submissions

A guide to the new disaggregated data questionnaire for drug submissions Health Canada uses disaggregated data to analyze the safety and efficacy of health products. The collection and analysis of disaggregated data in clinical trials is key to scientific rigour. This data: confirms that the diversity of clinical trial participants reflects the population groups that will use the product , and is used by sponsors and Health Canada to look at a drug’s safety and efficacy by subpopulation, where feasible. The data may also indicate if we need to verify a product’s safety or efficacy in certain populations through post-market monitoring. 2023-09-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetydrug submissionsdisaggregated dataanalysis of disaggregated-dataquestionnaire for drug-submissionssafety-and-efficacy of health-productsclinical-trialsdiversity of clinical-trial A guide to the new disaggregated data questionnaire for drug submissions HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/disaggregated-data-questionnaire-submissions.html A guide to the new disaggregated data questionnaire for drug submissions HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/essais-cliniques/questionnaire-donnees-desagregees-presentations.html

Health Canada uses disaggregated data to analyze the safety and efficacy of health products. The collection and analysis of disaggregated data in clinical trials is key to scientific rigour. This data: confirms that the diversity of clinical trial participants reflects the population groups that will use the product , and is used by sponsors and Health Canada to look at a drug’s safety and efficacy by subpopulation, where feasible. The data may also indicate if we need to verify a product’s safety or efficacy in certain populations through post-market monitoring.

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