The Stephenson Cancer Center places the highest priority on ensuring the safety of subjects participating in clinical trials as well as the quality of data obtained from clinical and translational research. The Data and Safety Monitoring Committee (DSMC) is responsible for overseeing all aspects of data auditing (verification of data validity and integrity) and safety of participants related to interventional treatment clinical trials.
The DSMC is responsible for:
- Reviewing all interventional investigator-initiated trials (IITs) conducted at the cancer center for data validity and safety, including all adverse event reporting as defined in the protocol
- Reviewing routine audit reports from the cancer center’s Data Integrity Core
- Reviewing protocol decision points (e.g., Phase I dose cohort, Phase I/II, and Phase II two-stage design transitions) to ensure compliance and safety
- Recommending corrective action plans to the Principal Investigator (PI) and the Associate Director for Clinical Research
- Notifying external sites (for multi-institutional trials coordinated by the Stephenson Cancer Center) of adverse events and required corrective actions
- Notifying the NCI of temporary or permanent suspension of NCI-funded clinical trials (if necessary)
The frequency of DSMC monitoring depends on the level of risk, and size and complexity of the clinical trial. In general, the risk assessment of a clinical trial is determined by its phase/type.
The functions of the DSMC do not overlap with the Protocol Review and Monitoring Committee (PRMC) or the Institutional Review Board (IRB).