The UPCI Data Safety and Monitoring Committee (DSMC) provides oversight of safety and compliance by regularly reviewing Disease Center meeting minutes and frequency and severity of adverse events. Interim DSMC meetings are scheduled to address specific issues that require immediate attention to ensure subject safety. The DSMC also assesses relevant new information, such as published scientific reports, or other developments that may affect subject safety or ethical concerns. The DSMC review is done to determine if there are changes to the anticipated risk/benefit ratio of a study that would affect its continuation.
UPCI and UPMC CancerCenter clinical trials are discussed at regularly scheduled Disease Center meetings involving the PI, co-investigators, and the clinical research coordinator. These discussions include each subject's treatment as described in the protocol and any significant toxicities that occur. The summary of these meetings is forwarded to the UPCI DSMC for review. The DSMC has the authority to suspend accrual or further investigative treatments to any trial based on information received that warrants this action.
The DSMC also monitors compliance to protocols and ensures proper submission of non-compliance documentation to the appropriate IRB(s).