Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects

Frequency: every 2 years

Training in Part C, Division 5 of the Food and Drug Regulations is a Health Canada required expectation. Given this, St. Michael’s Hospital has mandated training in Division 5 for anyone involved in conducting research activities for Health Canada regulated clinical drug trials at the Hospital.

Quick links


FAQs

Effective January 1, 2016, Division 5 – Drugs training is mandatory for all research staff conducting a Health Canada regulated clinical drug trial.

 

The Health Canada Division 5 – Drugs course can be found on the Collaborative Institutional Training Initiative (CITI) program website.

The first time you access the CITI website, you will need to create an account. Be sure to set your institutional affiliation to St. Michael’s Hospital when prompted so that our training records are automatically updated.

You can pause and return to the training course if necessary. Just be sure to remember your username and password so that you can log back in and resume the course. For ease of access, you may wish to bookmark the website.

The Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects course consists of 5 modules that focus on the basics of Division 5, the application for authorization, amendments/notifications and sponsor obligations.

Estimated time to complete course: 1.5 to 2 hours (approximately 20-30 minutes per module, each followed by a short quiz)

A mark of 80 per cent is required to pass. At the end of the course you will be issued a certificate of completion that you can print or e-mail to yourself for your records.

If you completed the CITI Health Canada Division 5 – Drugs course under a different affiliation (i.e., you did not choose St. Michael’s Hospital as your institution) or you have completed equivalent Division 5 training within the last two years, please email your training certificate to Dina Coronios (CoroniosD@smh.ca) in the Office of Research Administration so that we can manually update our training records.