Health Canada Submission Process
All clinical trials for which a Sunnybrook investigator is fulfilling the role of Sponsor-Investigator in Canada and requires 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.
What is a Sponsor-Investigator?
A Sponsor-Investigator is an individual who both initiates and conducts/manages a clinical trial (Sponsor); and under whose immediate direction the investigational product is administered to, dispensed to, or used by the study participant (Investigator).
When is a Sunnybrook investigator fulfilling the role of Sponsor-Investigator?
A Sunnybrook investigator most commonly fulfills the role of Sponsor-Investigator when initiating and conducting Sunnybrook Investigator-Initiated clinical trials for which they are responsible for filing for Health Canada authorization.
A Sunnybrook investigator may also fulfill the role of Sponsor-Investigator when participating in research initiated and conducted by others (i.e. consortium) located in jurisdictions other than Canada (i.e. United States) that require/request the Sunnybrook investigator be responsible for filing for Health Canada authorization.
What are the regulatory obligations of a Sponsor-Investigator?
A Sponsor-Investigator must fulfill all the regulatory obligations of the sponsor AND investigator as outlined in the Regulations (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.