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Data Safety and Monitoring Committee

The 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.

UPMC Hillman Cancer Center 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 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).

Specific DSMC Responsibilities

  1. Review all internal related or unrelated SAE reports and unanticipated events from studies to assess if there is a change in the risk/benefit ratio that might affect study continuation.
  2. Submit recommendations for corrective actions to the Principal Investigator.
  3. Review minutes from data safety monitoring committees external to UPMC Hillman Cancer Center (i.e., Phase I, Phase II, Phase II, IV Prevention Trials). Also review scientific reports or other literature that may have an impact on subject safety or continuation of the trial.
  4. Review other matters that pertain to serious errors or potential misconduct by any of the trial investigators and their research staff. Examples are major protocol violations or breeches in subject or sponsor confidentiality.
  5. Review any other matters that present safety issues to subjects enrolled on clinical trials not addressed above.