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
If you have any questions about this, please contact Nancy Wainman, IND Study Coordinator, at firstname.lastname@example.org.