The Data and Safety Monitoring Plan will involve the continuous evaluation of safety, data quality and data timeliness. Investigators will conduct continuous review of data and patient safety at their regular disease group meetings (at least monthly) and the discussion will be documented in the minutes.
The principal investigator (PI) of the trial will review toxicities and responses of the trial, where applicable, at the disease group meetings and determine if the risk/benefit ratio of the trial changes. The frequency and severity of adverse events will be reviewed by the PI and compared to what is known about the agent/device from other sources, including published literature, scientific meetings and discussions with the sponsors, to determine if the trial should be terminated before completion.
Serious adverse events and responses will also be reviewed by the OSUCCC – James Data and Safety Monitoring Committee (DSMC). The PI will also submit a progress report of the trial (biannually for phase II and quarterly for phase I) that will be reviewed by the committee per the DSMC plan. All reportable serious adverse events will also be reported to the Institutional Review Board (IRB) of record as per the policies of the IRB.