Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. The nineteenth installment in our Clinical Research 101 series is by Dana Nohynek, Director of Regulatory Affairs and Quality Assurance.
Dana Nohynek is the Director of Regulatory Affairs and Quality Assurance at the CIHR Canadian HIV Trials Network (CTN) at CHÉOS. She leads the regulatory and quality affairs functions through the management of infrastructure and guidelines for creating, maintaining, and enhancing administrative, regulatory, and quality assurance systems associated with conducting clinical trials. If you would like to inquire about our services, please submit your request here.
Clinical Trial Record Retention Period Reduced For Drugs and Natural Health Products
Health Canada has recently announced a reduction of the retention period for clinical trial records for drugs, biologics and natural health products from 25 years to 15 years. This change reflects amendments to the Food and Drug Regulations and Natural Health Products Regulations. These amendments came into force on February 11, 2022 as part of the Regulations Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19.
Previously, clinical trial sponsors were required to maintain clinical trial records for 25 years. The new shorter period reflects sponsors’ concerns about the cost and administrative burden the 25-year requirement placed on them. The new 15-year retention requirement also more closely aligns with international regulatory partners, reducing the burden to sponsors.
The new requirement to keep records for 15 years applies to sponsors of i) clinical trials of all drugs and natural health products with ongoing record retention obligations prior to February 11, 2022, and ii) any new clinical trials authorized on or after February 11, 2022.
The period for keeping records starts on the date the record is created. However, Health Canada’s Notice indicates that to simplify the process, sponsors may choose to “start the clock” for keeping all study records when the trial is completed (e.g., or terminated, ensuring that the retention period for each document from the clinical trial ends at the same time.
Health Canada will be updating the policies, guidance documents, and other documents accordingly.