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.

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Dernière modification avril 17, 2026, 21:46 (TU)
Créé le avril 17, 2026, 21:46 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2022-10-03 00:00:00
open_canada_keywords {"fr": ["présentations de médicaments", "données désagrégées", "analyse de données désagrégées", "questionnaire pour les présentations de médicaments", "innocuité et efficacité des produits de santé", "essais cliniques", "diversité des essais cliniques"], "en": ["drug submissions", "disaggregated data", "analysis of disaggregated-data", "questionnaire for drug-submissions", "safety-and-efficacy of health-products", "clinical-trials", "diversity of clinical-trial"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Guide du nouveau questionnaire sur les données désagrégées pour les présentations de drogues
update_frequency as_needed