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).

The DSMC reviews study information depending on type of trial (as outlined below) and may recommend a Full Approval, a Conditional Approval, or a Suspension.

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

Key Contacts

DSM@fredhutch.org for assistance with data and safety monitoring functions

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