Within the University of Virginia Cancer Center, the Protocol Review Committee, and the Data and Safety Monitoring Committee provide the infrastructure for scientific oversight and monitoring of institutional cancer related clinical trials. The Data and Safety Monitoring Committee provides oversight of the conduct of all ongoing UVa investigator-initiated clinical trials that have been approved by the Protocol Review Committee. For those studies the committee is charged with monitoring, their duties include review of study specific data and safety monitoring plans; adverse events including frequency and patterns of adverse events; protocol violations; audit findings; accrual rates; and adherence to protocol specific escalation or deescalation guidelines, or early stopping guidelines. The protocol specific risk.level assigned by the Protocol Review Committee determines the degree of monitoring.
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