PROTOCOL REVIEW MONITORING SYSTEM

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9.2 Clinical Trials Protocol Review & Monitoring Committee As part of our NCI designation, the Chao Family Comprehensive Cancer Center's (CFCCC) Clinical Trials Protocol Review & Monitoring Committee (CTPRMC) serves as the primary Protocol Review and Monitoring System (PRMS). The CTPRMC reviews trials for scientific merit, adequacy of study design, and biostatistical concerns. The Committee also monitors trial accrual on an ongoing basis. The CTPRMC membership reflects the expertise required for the scientific review of trials and consists of CFCCC members and other faculty and staff from diverse fields necessary for complete review of investigator-initiated and pharmaceutical company sponsored trials. Currently, all studies involving cancer patients, including investigator-initiated protocols and industrysponsored trials, must undergo review by the CTPRMC prior to submission to, and review by, the Institutional Review Board (IRB). Studies that do not involve an intervention, such as observational, registry, specimen repository, and retrospective chart reviews studies, may qualify for CTPRMC exemption, as determined by the Director of the Clinical Research Office. In addition, cooperative group trials are exempt from initial review by the CTPRMC if they have received prior peer review by both the cooperative groups and the Clinical Trial Evaluation Program (CTEP). However, monitoring accrual for these trials remains a CTPRMC obligation. Prioritization of these trials is determined by the disease-specific groups at the CFCCC, supervised by the Associate Director for Clinical Research of the CFCCC. The CTPRMC meets twice monthly (alternating full Committee and sub-Committee), to review the essential protocol elements, including clear rationale, appropriate and efficient study design, biostatistical input, attainable accrual, and feasibility for completion within a reasonable time frame.