This manual is based on Health Canada's Guidance for Clinical Trial Sponsors: Clinical Trial Applications and other applicable guidance documents. It is designed to provide tools and relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada.
The information provided within this package is for clinical trials that involve the use of Pharmaceutical and/or Biological and Radiopharmaceutical drugs in human subjects.
The information does not apply to clinical trials involving Medical Devices and Natural Health Products.
This manual is an administrative instrument only and does not constitute part of the Regulations. In the event of any inconsistency or conflict, the Regulations take precedence over this document.