ASK JEAN: Clinical Trial Records
15 March 2022
Clinical Trials BC Chronicle Spring 2022 – by Jean Smart, Regulatory Affairs and Quality Officer, Clinical Trials BC
Question:
Has the period for archiving site Investigator file or trial Master files for clinical trials changed ?
Answer:
Yes! On March 3, 2022, Health Canada posted a notice that they had reduced the period for keeping clinical trial records for drugs and natural health products from 25 years to 15 years.
This change has been amended to the Food and Drug Regulations and the Natural Health Products Regulations. This shorter period is intended to help with concerns around the cost and administrative burden of keeping records for a quarter century.
Note: This change has already been in force since February 11, 2022 for COVID-19 medical device and drugs as part of the Regulations Respecting Clinical Trials for Medical Device and Drugs Relating to COVID-19.
Health Canada will be updating the policies, guidance documents and other documents which currently do not align with this change.
Before proceeding to destroying clinical trial records, sites should check institutional administration for policies and obtain authorizations to destroy the records from the sponsor and/or the qualified investigator or designated steward of the records as applicable. Standard operational procedures related to the destruction of clinical trial records should be in place and followed. The process of destruction should be witnesses, documented, and retained with site historical records.
The unignorable irony in which one must document the destruction of the records, cannot be overlooked!
