Description

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.

Resources

Name	Format	Description	Link
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

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