The Data and Safety Monitoring Committee [DSMC] of the OSUCCC is responsible for overseeing all data and safety monitoring activities to include review of data and safety monitoring reports for local, investigator- initiated clinical trials. As specified in the OSUCCC DSM Plan, trials monitored include phase I and phase II trials of anti-tumor agents and regimens as well as studies of chemopreventive agents. Randomized phase III trials are required to establish independent DSM Boards to monitor data and safety. The DSMC consists of six members appointed to two-year terms by the OSUCCC Associate Director for Clinical Research. At monthly meetings, the DSMC reviews DSM reports submitted during the previous month. DSM reports are required quarterly for phase I trials and combined phase 1/11trials and biannually for phase II trials and cancer control studies. Reports use standard phase 1/11templates and include 1] trial accrual information, 2] demographic data listings, 3] safety/adverse event data tabulations by dose level, and 4] individual listings for all serious adverse events. Following DSM report review, the DSMC makes a recommendation to the OSUCCC Associate Director for Clinical Research of trial continuation, trial suspension requiring additional data, or trial termination for reasons of safety. The accrual and treatment of patients on trials with DSM reports delinquent by more than one month from the required submission date will be suspended until the report is submitted and receives a recommendation of continuation from the DSMC. With 23 investigator- initiated trials currently requiring local DSM, the DSMC reviews 6-8 DSM reports monthly. While reports are currently submitted as hard copy documents, efforts to electronically generate reports from Clinical Research Information System independent of study principal investigators are underway.
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