Canadian Cancer Trials Group Bulletins

Trial Management Group

Canadian Appendix for Intergroup Trials

To facilitate centre participation on intergroup trials (Canadian Cancer Trials Group trials that are led by other cooperative groups), we have created a stand alone document called the "Canadian Appendix". This document describes Canadian-specific participation procedures, as well as any aspects of the protocol that might vary for Canadian centres. For example, since all randomizations must be done via the Canadian Cancer Trials Group, the randomization process outlined in the protocol does not apply to Canadian sites; hence, all sites must refer to the Canadian Appendix for enrollment details. Similarly, there may be differences for participating Canadian sites in drug supply, SAE reporting, and CRF submission.

Please be sure to refer to the Canadian Appendix for your Intergroup trials and use it as a supplement to the protocol. The Canadian Appendix is posted to each trial website adjacent to the main protocol. Throughout the course of the trial, this appendix may be updated as required. You will always be informed when this occurs and will be provided with a summary of the changes.

As always, if you have any questions regarding Canadian participation on Intergroup trials, please do not hesitate to contact the trial Study Coordinator listed on the Canadian Cancer Trials Group trial web page.