Data and Safety Monitoring/ NIH Policy

University Of Wisconsin-Madison, Madison WI

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY (See instructions): The Data and Safety Monitoring System (DSMS) of UW Carbone Cancer Center (UWCCC) ensures that all clinical research being conducted under the auspices of UWCCC is in compliance with federal requirements and most importantly that human subject safety is always optimized. The DSMS is assisted in its mission of safety and compliance by experienced UWCCC research staff, a Data and Safety Monitoring Committee (DSMC) composed of experienced clinical researchers, and the ongoing use of the Clinical Research Management System (CRMS), OnCore by Forte Research Systems, which allows efficient tracking of protocols and protocol subjects. The DSMC reviews reports on quality assurance (internal audits, quality assurance reviews, response reviews, protocol summary reports, and compliance reviews), protocol deviations/non-compliance, and serious adverse events. The DSMC also provides data review, data abstraction and entry, forms monitoring and final report generation for studies developed and solely monitored by UWCCC. The DSMC is chaired by Anne Traynor, M.D., Associate Professor of Medicine, and co-chaired by KyungMann Kim, Ph.D., Professor of Biostatistics and Medical Informatics, each with over 15 years of clinical trials experience.