9.2 Protocol Review and Monitoring System (PRMS) Overview Effective expansion of the DF/HCC clinical research capability is dependent upon a fully integrated clinical trials infrastructure serving oncology research efforts. The Protocol Review and Monitoring System (PRMS), which oversees the scientific design and progress of DF/HCC clinical trials, is a critical component of that effort as it ensures that new protocols are important, well designed and are feasible within a reasonable timeframe. The PRMS system includes: ? The initial scientific development and review that is performed through the Disease Programs; ? The formal evaluation for merit, feasibility and priority that is performed by the centralized Scientific Review Committee;and ? The oversight for scientific process and data quality assurance that is performed by the Clinical Investigations Policy and Oversight Committee (CLINPOC). With the integration of BIDMC and consequently an expansion of our clinical trials to additional investigators and protocols, PRMS now assures scientific quality for all recently activated BIDMC research oncology protocols as well. The current operational scheme for clinical trial development, approval, activation, and support is shown in Appendix 2 included at the end of section 9.1.14, CROC. Each of these components has been described in the preceding section on CROC and will be illustrated in more detail below. The process for the scientific review of new and active protocols will be highlighted in the initial portions of this section. Once these systems have been described, the results of scientific review and oversight will be presented.
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