Health Canada Submission Process
All Sunnybrook Research Institute (SRI) Investigator-initiated Clinical Trials subject to Health Canada regulations requiring submission of a Clinical Trial Application (CTA) to Health Canada must follow a Centralized Review Process facilitated by Quality Assurance and Education (QA&E) at Sunnybrook under the direction of the Human Research Protections Program (HRPP).
For SRI Investigator-initiated regulated Clinical Trials, SRI is designated the sponsor on the CTA to Health Canada. SRI will delegate some of its sponsor responsibilities to the Qualified Investigator (QI) as outlined in the Investigator Responsibilities for the Conduct of Clinical Trials policy (SRI-044). The policy includes the responsibility of filing for Health Canada authorization.
A Sunnybrook investigator may also fulfill the role of QI when participating in research which is initiated/conducted by others (i.e. consortium) located in jurisdictions outside of Canada (i.e. United States) that requires SRI as the sponsor to be responsible for filing for Health Canada authorization.
SRI Investigator-initiated regulated Clinical Trials must comply with all regulations that are applicable to the sponsor as well as the QI (see below).
All clinical trials filed with Health Canada must comply with;
• The International Conference on Harmonization (ICH) Guidance for Good Clinical Practice (GCP).
All clinical trials filed with Health Canada must also comply with their product specific regulations (see below);
For Pharmaceutical, Biological and Radiopharmaceutical Drugs
• Part C (Drugs) Division 5 (Drugs for Clinical Trials Involving Human Subjects) of the Food and Drug Regulations 2001.
For Natural Health Products
• Part 4 (Clinical Trials Involving Human Subjects) of the Natural Health Products Regulations 2003.
For Medical Devices
• Part 3 (Medical Devices for Investigational Testing Involving Human Subjects) of the Medical Devices Regulations 1998, and
• International Organization for Standardization (ISO) Clinical investigation of medical devices for human subjects - Good clinical practice 2011 (ISO 14155).
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Additionally, all clinical trials submitted to the Sunnybrook Research Ethics Board (REB) must comply with;
• 2nd Edition of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2010 (TCPS2), and
• The provisions of the Ontario Personal Health Information Protection Act (PHIPA) 2004.