Canadian Cancer Trials Group Bulletins

Ethics Regulatory

Changes in Safety Policy

The Canadian Cancer Trials Group expects centres to submit to their REBs only Unanticipated Problems (UP), which include the significance of the report to the trial and outline any proposed protocol or informed consent changes or other corrective actions to be taken as a result of the event(s).

All other safety reports (SAEs which do not require a change to the protocol or consent, Safety Updates, etc) will continue to be posted to the web-based safety reports monitoring utility to ensure Investigators have full access to all safety information related to the trial. These reports will be identified in the utility as Not Req'd (not required) under the Local REB Notification Date field.

Appropriate adjustments to the web-based safety reports monitoring utility will be made for existing reports on September 20, 2010.

Please see the memo posted at

Further information on Canadian Cancer Trials Group's safety policy can be found on the (newly updated) Canadian Cancer Trials Group website at

For questions, please contact Bryn Fisher, Safety Team Leader, at or 613- 533-6430.