Canadian Cancer Trials Group Bulletins

General


Follow-Up Requirements for Closed IND Studies

We are aware that the need to submit a final report at the time of death on all patients entered on phase I or II Canadian Cancer Trials Group IND studies represents a significant workload for participating centres, both in terms of patient follow-up, and the requirement for REB annual re-approval. Accordingly, a review of closed IND studies was undertaken recently, and the requirement for continued follow-up on these studies, and on IND studies in general, was discussed.

A memo and Appendices from Dr. Elizabeth Eisenhauer, Investigational New Drug Program Director, was sent to centres in November, 2008 which outlines this discussion and the revised requirements for patient follow-up and REB annual re-approvals.

Please use these links to view the memo and appendices:

Cover Letter - 2008 SEP 22
Appendix A
Appendix B


If you have any questions about this, please contact Nancy Wainman, IND Study Coordinator, at nwainman@ctg.queensu.ca.