Frequency: every 2 years
Training in Part C, Division 5 of the Food and Drug Regulations is a Health Canada required expectation. Given this, Unity Health Toronto has mandated training in Division 5 for anyone involved in conducting research activities for Health Canada regulated clinical drug trials at Unity Health.
The Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects course can be found on the Collaborative Institutional Training Initiative (CITI) program website.
*This link will take you to the CITI home page. For information on account creation, logging in, and finding and completing the course, please see the FAQs below.
Effective January 1, 2016, Division 5 – Drugs training is mandatory for all research staff conducting a Health Canada regulated clinical drug trial.
To create an account users should go to the CITI website and click on “Register”. The organization affiliation is “Unity Health Providence St. Joseph’s and St. Michael’s Healthcare (N2)”.
It is preferred that you use your Unity Health email address when registering.
When logging in in the future, use the regular “Log In” option (not Log In Through My Organization).
Once logged in, you can find the Division 5 Course by going to My Courses > View Courses. If the course does not appear on this page, there is a link at the bottom of the page to add a course.
The course is called Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects.
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).
You can pause and return to the training course if necessary.
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 have completed Division 5 training within the last two years under the affiliation of another organization, a copy of the training certificate must be provided.
Submit external training certificates to the Research Ethics inbox (researchethics@unityhealth.to).
