Data and Safety Monitoring Committee

Cancer-related investigator-initiated trials with an intervention involving a drug, device, or biologic are subject to review by the Data and Safety Monitoring Committee (DSMC).

DSMC reviews study information depending on type of trial (as outlined below) and may recommend continuation, suspension, or closure of a study.

A DSMC Annual Renewal Form is required for all studies undergoing review by the DSMC.

Study Information Reviewed by the DSMC

Number of subjects
Unanticipated problems
List of Stopping Rules met – if applicable
List of Dose Limiting Toxicities and responses that have occurred in the specified time frame
Premature terminations of investigational treatment and other safety issues
Cumulative table of adverse events by type and grade, including deaths as outlined in the protocol-specific DSMP
Compliance data from monitoring, auditing, and noncompliance reports

Number of subjects
Unanticipated problems
DSMB minutes and reports for accrual, stopping rules, adherence to protocol DSMP, and DSMB recommendations
Cumulative table of adverse events by type and grade, including deaths as outlined in the protocol-specific DSMP