Data and Safety Monitoring
Chair: Max W. Sung, MD
All cancer clinical trials conducted at Mount Sinai Medical Center require monitoring and are required to follow guidelines outlined in The Tisch Cancer Institute (TCI) data safety and monitoring plan (DSMP). To ensure that clinical interventional trials in the TCI are initiated and conducted with attention to data safety and monitoring, and as part of the overall TCI DSMP, a data and safety monitoring committee (DSMC) has been constituted.
The objectives of the DSMC are:
1. To review the data and safety monitoring plans for study protocols submitted to the TCI Protocol Review and Monitoring Committee (PRMC).
2. To review, on an ongoing basis, data regarding safety and efficacy from study protocols approved by the TCI PRMC and the Mt. Sinai IRB which are moderate or high risk to ensure that the safety of study participants is maintained.
3. To serve as the primary Data and Safety Monitoring Board (DSMB) for all phase III cancer clinical trials, and other phase clinical trials at request of the principal investigator or PRMC that do not have a separately commissioned, and IRB approved internal or external data safety and monitoring committee.