Protocol Review and Monitoring System

PROJECT SUMMARY/ABSTRACT The Protocol Review and Monitoring System (PRMS) of the Tisch Cancer Institute (TCI) oversees all cancer related clinical research conducted at the Mount Sinai Health System (MSHS). The primary goal of the PRMS is to assure robust internal oversight of the scientific aspects of cancer-related research by providing a rigorous initial scientific review and performing ongoing monitoring for scientific progress and accrual of active cancer protocols. Protocol review is performed in a two-stage review process: Disease- or Modality-Focus Groups, and the Protocol Review and Monitoring Committee (PRMC). This 2-stage review process increases efficiency by (i) supporting staff effort in developing protocols and PRMC application materials of greater scientific merit, (ii) reducing the time from concept approval to protocol activation, and (iii) improving the quality while reducing the volume of protocols reviewed by the PRMC. The PRMC has the authority to approve protocols that meet the scientific merit and priorities of the TCI and to terminate protocols that do not demonstrate scientific progress.