Canadian Cancer Trials Group Bulletins

General


Single-Study Centres and DSMC Summary Reports

The Canadian Cancer Trials Group Data Safety Monitoring Committee (DSMC) met via teleconference on November 23, 2009.

Trial-specific DSMC Summary Reports are now posted on trial websites. Single-study centres participating on these trials should download these reports and submit them to their REBs. These trials include: BR.19, BR.25, BR.29, CE.6, CO.20, CO.21, HD.6, HN.6, LY.12, LY.13, MA.17R, MA.20, MA.21, MA.22, MA.27, MA.29, MA.31, MAP.3, MY.10, PR.3, PR.7, PR.11, PR.12, and SC.20.

It is a requirement of the NIH that information regarding the recommendations of the DSMC be sent to all participating centres, after each meeting, for submission to their local Research Ethics Board (REB). A copy of the relevant NIH guideline can be found at http://grants.nih.gov/grants/guide/notice-files/not99-107.html. As many Canadian Cancer Trials Group studies are affiliated with the NCI US, this NIH requirement must be complied with for NCI US-affiliated studies, and we recommend it be followed for other studies as well. Accordingly, centres should send the trial-specific Summary Report to their REB and retain documentation of the submission on file.

Questions can be directed to Heather Stanton at hstanton@ctg.queensu.ca or 613-533-6430.