The Protocol Review and Monitoring System (PRMS), under the leadership of Michael Bookman M.D., has been substantially modified in response to the critique of the previous site review. The PRMS includes the Research Review Committee (RRC), which provides the primary mechanisms for scientific evaluation of new and ongoing clinical research protocols, and has the authority to activate and close all clinical studies in conjunction with the Institutional Review Board (IRB). Administrative support is coordinated through another element of PRMS, the Protocol Management Office, which facilitates staff assignments, broad consideration of resource utilization and protocol staff review of operational details for each new study. The PRMS reports directly to the Senior Vice President for Medical Science, Dr. Ozols. During the last granting period, significant changes have occurred, including: a) the development of standardized forms for submission and review of protocols; b) increased written communication with the IRB; c) expanded collection of accrual data in a centralized relational database; d) mandatory annual scientific review of all active studies; e) automated generation of protocol-specific annual review materials; review of all protocol amendments; and f) early involvement of biostatisticians in protocol design and approval, prior to presentation at RRC. The PRMS underwent an additional peer review in 1996, consequent upon recommendations of the previous full site review, and was approved.
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