In order to respond diligently to the observations of Health Canada’s latest inspection in July 2024, and to ensure compliance with standard operating procedures at CHU de Québec-Université Laval (CHU), a clinical trial monitoring service was set up in the fall of 2024. 

Part C, Division 5 of the Food and Drug Regulations, “Drugs for Clinical Trials Involving Human Subjects”, and more specifically section C.05.010, which details the sponsor’s obligations, states, among other things, that the sponsor must implement a clinical trial monitoring process to ensure data quality and integrity, as well as monitoring all tasks and functions performed on its behalf (ref. C.05.010.c). The Establishment must therefore ensure that this good practice is respected. 

This fee-based service is mandatory for all clinical trials initiated by a researcher from the Centre de recherche du CHU de Québec-Université Laval (CRCHU) and for which the CHU is identified as the sponsor, and for which the monitoring plan has not already been implemented. This monitoring plan must also have been previously approved by Quality Assurance.