CORE--PROTOCOL REVIEW AND MONITORING

University Of Wisconsin Madison, Madison WI

Investigators

Linked publications, trials & patents

Abstract

The major function of the Protocol Review and Monitoring System (PRMS) is to provide a mechanism for scientific review and research oversight of all UWCCC clinical research trials. The Cancer Center has charged this oversight responsibility to two committees, the Clinical Affairs Committee (CAC) and Clinical Trials Monitoring Committee (CTMC). The CAC performs review of all new research relative to its scientific merit and priority within the UWCCC. The relationship between the CAC and the University of Wisconsin Human Subjects Committee (HSC) remains strong and complementary. The HSC relies heavily on CAC scientific review and, in its formal policy, continues to support CAC authority to active, disapprove, or terminate UWCCC trials. The CTMC monitors the progress of all ongoing clinical trials reporting their findings to the CAC. An additional PRCS activity involves the monitoring oversight of cancer control/non-treatment trials, the review of all quality control and safety reports. These two committees report to UWCCC senior leadership of cancer control/non-treatment trials, the review of all quality control and safety reports. These two committees report to UWCCC senior leadership through the Clinical Research Committee (CRC) for all their activities.