What information do I need to report during and after a clinical trial?

Any changes to the information in the clinical trial application (CTA) or the Clinical Trial Site Information form must be submitted to Health Canada in the form of an amendment or a notification.

If a trial ends prematurely, Health Canada must be informed within 15 days after the date of discontinuance. Any refusals from regulatory authorities or Research Ethics Boards (REBs) must also be disclosed to Health Canada.

Other events that require reports to Health Canada and the REB include:

  • adverse drug reactions
  • progress or findings of the study
  • lot-release information for biologics and radiopharmaceuticals

Health Canada requires that you submit an Investigator’s Brochure each year, and all clinical trial records must be stored for 25 years for those that required a CTA. All other clinical trial records must be kept for 7 years, according to AHS policy.

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