All studies are subjected to rigorous review before initiation, annual review, and review of all study amendments. In addition, all studies are at risk for an in-depth data audit as conducted by the Monitoring Committee. Accrual to all locally initiated studies is monitored by the shared resource. Studies with low accrual are identified at the time of annual review. Investigators are invited to justify continued operations with an explanation, revised accrual plan, or, if appropriate, studies are terminated.
Safeguards are in place to prevent excessive accrual as well.
In cases in which accrual might appear to be excessive, the potential problem is brought to the attention of the Principal Investigator or, if appropriate, the shared resource Director. Local and national events that reflect upon current and emerging standards for clinical trials research, including implementation of human subjects' protections and standards for research quality, are highlighted.