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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).

Regulations

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).
Note: Access to this document is restricted by copyright license. Contact Quality Assurance and Education for user access and more information.

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.