PROTOCOL REVIEW AND MONITORING SYSTEM

Scientific review and oversight of clinical trials at the AECC is a function of the Protocol Review and Monitoring System (PRMS). The primary objective of the PRMS is to assure that clinical research performed at the AECC is of the highest quality. Specifically, the functions of the PRMS are: a) To review all new protocol submissions and amendments to evaluate their scientific merit and feasibility, (b) To monitor accrual to ongoing studies on a continuing basis, to assure that protocols meet their accrual goals in a timely fashion, thus assuring that the research goals are met. (c) To ensure that there are no competing studies with completely overlapping eligibility, and that there is adequate justification and patient resources in circumstances where it may be desirable to have more than one protocol for a specific indication, (d) To provide recommendations as to whether AECC investigator-initiated studies are of sufficient scientific merit to warrant allocation of Protocol Specific Research Support (PSRS) and/or other resources required for conduct of the study. The PRMS functions are carried out by the Protocol Review and Monitoring Committee (PRMC). Members of the PRMC are selected both to assure broad representation from the oncology clinical research community and to assure the highest quality of review. Members are chosen who represent the different clinical disciplines (e.g., surgery, adult-, pediatric-, medical-, gynecological- and radiation- oncology; pathology, radiology) and therapeutic modalities (i.e. cytotoxic therapy, immunotherapy, radiation), as well as expertise in various stages of drug development (Phases I, II, III trials) and translational science. The committee also includes representatives from, nursing, pharmacy, data management, and biostatistics, a member from the AECOM CCI not associated with AECC, and an external member.