Protocol Review and Monitoring System (PRMS)

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PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring Committee (PRMC) of the Kimmel Cancer Center (KCC) is an integral component of the KCC clinical investigations activities. The KCC PRMC reviews all new research proposals involving human subjects and neoplastic diseases. Proposals receive a pre-review by the pertinent disease-specific working group, which provides a written evaluation of protocol feasibility, lack of competitive protocols or stratification if overlap with other protocols exists, and compatibility with KCC research and accrual goals. The Clinical Research Management Office (CRMO) staff prepares the documentation and coordinates meetings and communications for the PRMC. The specific aims of the PRMC are to (1). Maintain a review committee of KCC investigators, with representation from basic science and clinical areas, responsible for the initial scientific review and monitoring of all ongoing clinical trials, (2) Evaluate the scientific merit of new proposals, (3) Establish criteria for prioritizing competing KCC studies, (4) Monitor accrual to clinical studies and terminate those studies that fail to meet objectives based on protocol specifications in a timely manner, (5) Maintain a collaborative relationship with the University Institutional Review Board and the KCC Data and Safety Monitoring Board (DSMB) to facilitate interaction between the three review committees, (6) Assure protocol compliance through the review of data audits conducted by the CRMO. The PRMC initial scientific review of each proposed study focuses on: (1) study value; (2) methods; (3) investigator(s) experience and (4) patient resources. The PRMC considers one of five actions for each study: (1) approved as written, no changes required; (2) approved with advisory changes only, no further committee action required; (3) approved in concept with changes or justification requested; (4) tabled for additional investigator input/clarification or (5) rejected. The PRMC holds regular meetings twice per month during which each protocol involving human subjects submitted to be opened at KCC is discussed and evaluated. Investigator-initiated and industry-sponsored protocols undergo rigorous full scientific peer review, including biostatisties, as well as pharmacy, nursing, financial and workload review. All National Cancer Institute cooperative group protocols are eligibl e to undergo expedited review to prioritize for implementation. In the period 1/1/06-12/31/06, 59 protocols were submitted for PRMC review. Of these, 26 were cooperative group; of the remaining 33 protocols, 6 were externally peer reviewed protocols, 14 were investigator initiated protocols and 13 were industrial protocols. In the period 1/1/06- 2/31/06 36 protocols were approved and activated, 14 were deferred for revision, 16 were approved but not activated in this time frame, and 7 were ultimately disapproved.