Canadian Cancer Trials Group Bulletins

Trial Management Group

Implementing Canadian Cancer Trials Group Protocol-Specific Training

Canadian Cancer Trials Group, as sponsor in Canada, is required to ensure personnel at our member sites have undergone ICH-GCP and ethical trial conduct training prior to participating on our trials. Furthermore, in accordance with GCP, training is also required on the study protocol/amendment(s), investigational medicinal product and trial procedures and duties for all investigational new drug (IND), phase III and intergroup-led trials.

To facilitate training, and to ensure compliance with these requirements, a web-based Site Training Utility (STU) has been developed. This system will serve as a central repository for training material. Protocol-specific training slides will be available, as well as certificates/reports to document training completion.

This initiative is currently being piloted on IND.206 and IND.207. Over the coming months, the Site Training Utility will be introduced for newly-activated trials, as well as select active trials. In future, all trials will require completion of protocol-specific training through this utility prior to local activation of a centre. In addition, training for trial amendments will be delivered via this system, when applicable.

Protocol-specific training will be mandatory for the Principal Investigator of the trial at each participating site. In accordance with ICH-GCP, the Principal Investigator will then ensure that all local personnel delegated significant trial-related duties are appropriately trained per local policy. To facilitate local training needs, all those listed on the Trial Participants List will have access to the Site Training Utility. Participating sites are welcome to use the system to document staff training, if desired, in accordance with local Standard Operating Procedures.

We will provide a demonstration of the new Site Training Utility at the upcoming annual Spring Meeting and we look forward to sharing this new initiative with you!