Canadian Cancer Trials Group Bulletins

Office of Compliance and Oversight


Canadian Food and Drug Regulations Div. 5 Training Update

On March 2nd, 2015 Canadian Cancer Trials Group's new web-based Canadian Division 5 training program went live. The training program consists of a slide deck that summarizes the key aspects of Division 5 training and a short test consisting of a few questions. We requested that all active Canadian Cancer Trials Group members participating on our trials complete the training by June 1st, 2015. An additional grace period was granted however, this grace period is now drawing to a close.

Please note the following new deadlines for implementation of Division 5 (Canadian Food and Drug Act Regulations: Part C Division 5) training requirements.
  1. February 1, 2016: Completion will be mandatory for all NEW trials
  2. June 1, 2016: Completion will be mandatory for ALL trials (if CTA with Health Canada)
Thereafter, Canadian Cancer Trials Group members who have not completed the training (or provided proof of alternate training) will be marked as having "incomplete Division 5 training" in our roster until the training is complete. This means that you will not be able to participate on Canadian Cancer Trials Group clinical trials involving an investigational agent.

There are three ways to confirm your training
  1. If you have already completed a similar educational course (including as part of an investigator or start up meeting please contact training@ctg.queensu.ca.
  2. If you have already completed a similar educational course (including as part of an investigator or start up meeting please contact training@ctg.queensu.ca.
  3. Complete the Division 5 training program urgently. It is available in the toolbox on the Canadian Cancer Trials Group website at https://www.ctg.queensu.ca/public/ctg-toolbox. Click on the link under training for "Division 5 - Canadian Food and Drug Regulations" to access the program.
  4. We will provide "group" training by means of a Webex (early in January) if there is sufficient interest. If you are interested in such training please contact training@ctg.queensu.ca immediately.
  5. Important letters containing this information were recently sent out to investigators and other external participants who have not yet completed the required Division 5 training. If you received one of these letters please ensure that you confirm your training as soon as possible. If you didn't receive a letter but will be participating in a trial with an investigational agent in the near future, you should take the training now to prevent being stopped from participating in the future.

    If you have any questions please contact training@ctg.queensu.ca.