The goal of the Protocol Review and Monitoring System (PRMS) is to provide scientific oversight of cancer clinical trials conducted at City of Hope Comprehensive Cancer Center independent of the protection of human subjects afforded through the COM Institutional Review Board (IRB). This function is organized around the Cancer Center's Cancer Protocol Review and Monitoring Committee (CPRMC). City of Hope supports an internal Cancer Protocol Review and Monitoring Committee (CPRMC) to: 1) maintain the high quality of institutional clinical research;2) prioritize clinical research conducted by Cancer Center members; 3) provide a pathway for innovative clinical protocol research in the diagnosis, therapy, prevention and control of cancer to gain full access to shared resources and services supported by the Cancer Center Support Grant (CCSG). Scientific review requiring full committee vote is required for all new trials, amendments to on-going trials, and continuing trials?the latter on a yearly basis. The scientific review for new trials includes an evaluation of study design, scientific rationale, potential for accrual and biostatistical input for all new studies. Review of annual continuations includes an examination of actual accrual. Investigator-initiated Cancer Center-supported clinical protocols cannot have access to any of the Center's core facilities without full approval of the study by the CPRMC. Data and safety monitoring is conducted in compliance with the NCI-approved Data and Safety Monitoring Plan for Cancer Clinical Trials. This level of review provides an independent means of confirming the efficacy of the investigational treatment programs ongoing in the Cancer Center. The total annual budget of the CPRMC is $125,483 of which the institution pays 52% and CCSG funding is requested for $ 60,819, or 48% of the total. Total staffing for the core is 2.99 FTEs.
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