PrECOG employs a system for the oversight and monitoring of all studies to ensure patient safety, data integrity and data validity. The level of oversight is determined on a study by study basis and is commensurate with the anticipated safety risks, study size and complexity of the trial. One of the vehicles for this oversight is the Data Safety Monitoring Board (DSMB). PrECOG maintains a standing Global DSMB for its clinical trials and each individual study protocol will identify the need for a DSMB. The DSMB will meet at least annually or more often depending on the nature of the trial being monitored and the timeline defined by the protocol specific DSMB Charter. In addition to monitoring subject safety, scientific integrity and data validity, the DSMB may also monitor the timeliness of accrual, the quality of data collection and management, and the accumulating outcomes.

PrECOG Provides ECOG Enrollment Credit

ECOG leadership approved a proposal allowing accrual to PrECOG studies to count towards the ECOG Institution Evaluation. Beginning in 2008, ECOG will assign equivalent credits for PrECOG enrollments. The credits will count towards the ECOG Institutional Evaluation, but not towards the standard NCI reimbursement. Credit is assigned over a 12 month period beginning in March of each year.