Clinical Research Support

Data and Safety Monitoring Committee

All clinical trials subject to SRC review are required to submit information to the Data and Safety Monitoring Committee (DSMC) at annual renewal. This committee has replaced the Protocol Data Monitoring Committee (PDMC).

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

Study Information Reviewed by the DSMC

For all clinical trials within the Cancer Consortium:

  • Number of subjects
  • Unanticipated problems
     

Investigator-Initiated trials subject to review that do not have a DSMB:

  • 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
     

Investigator-Initiated trials subject to review that have a DSMB:

  • 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
     
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