The Clinical Protocol Scientific Review and Monitoring System of the Robert H. Lurie ComprehensiveCancer Center (Cancer Center) is composed of several key committees including the Clinical ProtocolScientific Review and Monitoring Committee (CPSRMC), Data Monitoring Committee (DMC), and the AuditCommittee. The CPSRMC is charged with the responsibility of evaluating all new and ongoing clinicalresearch protocols that have not received scientific review by an NCI-approved peer review group, focusingon the scientific review of new and on-going research. NIH requires that DSM activities be distinct fromactivities of the scientific review committee; therefore, a second committee, the DMC, is responsible forproviding data and safety monitoring for local, investigator-initiated protocols. The DMC meets twice a monthto review all open intervention studies that fall under its purview and is responsible for: 1) safety reviews ofall local, investigator-initiated clinical trials, 2) reviews of PI monitoring reports submitted for each trial, 3)progress reviews of all clinical trials, including on-going review of accrual, 4) reviews of all audit reportsgenerated by the Audit Committee, 5) reviews of all serious adverse events that occur, and 6) reviews ofprotocol exceptions/deviations. The Audit Committee was developed in 2001, and is responsible for theconduct of the annual auditing program for local, investigator-initiated protocols. This committee performscomplete audits including source document verification, regulatory compliance and drugaccountability/pharmacy compliance. Annually the committee audits two trials that are randomly selected,from which 10% of enrolled subjects are selected for review. The Cancer Center's Data and SafetyMonitoring Plan was originally approved by NCI in August of 2001 and has undergone three revisions sincethat time.
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