Protocol Review and Monitoring System

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Project Summary Protocol Review and Monitoring System (PRMS) The Perlmutter Cancer Center (PCC) Protocol Review and Monitoring System (PRMS), internally known as the Protocol Review and Monitoring Committee (PRMC), reviews all cancer-related clinical research under the jurisdiction of PCC and NYU Langone Health (NYULH). The objectives of the PRMC are to determine whether a protocol is scientifically and statistically sound, appropriately designed, feasible and not competitive with other ongoing studies at PCC. The PRMC also determines if protocols are aligned with PCC scientific priorities and the needs of our catchment area, evaluates whether accrual goals are realistic, and assesses the likelihood of trial completion. The PRMC has the ultimate authority to approve and prioritize, in an efficient and timely manner, the activation of cancer-related protocols that have a high level of scientific merit and meet the scientific priorities of the PCC. The PRMC also decides whether to terminate protocols that do not demonstrate acceptable progress. Investigator-initiated studies are reviewed for progress at least bi-annually, and other studies annually. All studies are reviewed more frequently if deemed necessary by the PRMC, due to low accrual or if protocol amendments significantly change the scientific design or accrual targets of the protocol. The PRMC is also charged with ensuring that all cancer-related clinical research at NYULH meets appropriate criteria for inclusion of women, minorities and children. The PRMC is fully integrated into the clinical trials review and approval systems of NYULH. In this context, it functions in a well-coordinated, expeditious, but non-overlapping manner with the NYULH IRB, Office of Science and Research (OSR), and various other NYULH review entities, including Environmental Health and Radiation Safety, Biosafety, and Investigational Pharmacy. Consistent with the Institutional agreement with the NCI, the NYULH IRB will not grant full approval to any cancer-related human subjects protocol without receiving documentation of PRMC approval.