Data and Safety Monitoring

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The Data and Safety Monitoring System.(DSMS) of the UWCCC ensures that all clinical research being conducted under the auspices of the 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 ONCORE database which allows more efficient tracking of protocols and protocol subjects. The DSMC reviews reports on quality assurance (internal audits, response reviews), protocol deviations and severe 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 the UWCCC. The DSMC is chaired and co-chaired by James Stewart, Professor of Medicine, and KyungMann Kim, Professor of Biostatistics and Medical Informatics, each with > 20 years of clinical trials experience.