Health Canada Notification on Clinical Trial Management During COVID-19 Pandemic
In response to the current COVID-19 public health emergency, Health Canada has published the notification Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors.
Health Canada acknowledges that protocol deviations may increase during the current pandemic. Sites should have a way to document such deviations and report them to the sponsor and REB according to those entities’ requirements. Sponsors are not required to report these deviations to Health Canada unless the deviations place participants at risk.
Processes may need to be changed to accommodate pandemic safety practices, such as using an electronic alternative to wet ink signatures. Sponsors who pause study recruitment or temporarily halt a trial should notify Health Canada using a clinical trial application notification (CTA-N).
Advarra has policies and processes in place to keep REB, IRB, IBC, and all other operations functioning as normal during the pandemic. For more information or to send Advarra a specific question about a study, please visit the Ask Advarra page and review the article Impact on COVID-19 Outbreak on Ongoing Research and Protocols Under Advarra IRB Review.