PrECOG News

Data Safety Monitoring Board

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. 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.

 

ECOG Enrollment Credit

ECOG sites will receive credit towards the ECOG annual institution evaluation for patients that are enrolled to PrECOG studies.  Credit is assessed over a 12 month period, typically beginning in March of each year.  ECOG Main Institutions are required to enroll 50 patients per year on ECOG studies, and enrollment to PrECOG studies will count towards meeting this requirement.  Sites are not reimbursed by ECOG for enrollment to PrECOG studies.  PrECOG enrollment will not count towards the CCOP credit requirements.