7.0 Protocol Review and Monitoring System (PRMS) Description The Cancer Protocol Review Committee (CPRC) functions as the Protocol Review and Monitoring System for the Masonic Cancer Center (MCC). The MCC Clinical Research Leadership (CRL) appoints the chair of the CPRC. Committee members may be selected by the CRL or the CPRC chair. Members are selected by area of expertise to form a diversified group of clinicians and other professionals able to provide rigorous scientific review of study rationale and design. The CPRC membership is divided into 2 subcommittees: the Therapeutic Interventional Committee, which meets twice monthly, and the Non-Therapeutic Interventional Committee, which meets monthly. The MCC Clinical Trials Office provides administrative support to both CPRC subcommittees. Protocol prioritization has been emphasized during the last granting period to ensure greater efficiency of clinical trial management and to optimize patient enrollment. Prior to CPRC review, protocols or protocol concepts are sent to the appropriate interdisciplinary site-specific cancer care (ISC) team for review. The purpose of the ISC teams is to identify the needs of the patients they see;identify appropriate clinical trials to address these needs from industry. Cooperative Group, and investigator-initiated resources;and prioritize enrollment of patients in clinical trials. The CPRC reviews each study with regard to the following criteria, and can approve, approve with stipulations, defer, or disapprove each study: * Purpose of study * Justification of study, including results of previous studies or pilot data * Inclusion/exclusion requirements * Treatment plan, including doses, dose adjustments, schedule, and duration * Description of all drugs, including chemical formula when available, known toxicities, methods of procurement, methods of storage, and other relevant information * Adequacy of the data and safety monitoring plan * Biostatistical support (investigator-initiated trials only) * Adequacy of the statistical section Time to protocol approval continues to be monitored with the aim of expediting clinical trial implementation. Ongoing post-approval review includes review of amendments, annual review, and accrual reviews.
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