Abstract: Protocol Review and Monitoring System (PRMS) Chaired by Leonard Appleman, MD, PhD, Hillman Cancer Center’s (HCC) Protocol Review Committee’s (PRC) (Protocol Review and Monitoring System (PRC/PRMS) goal is to promote the highest scientific caliber clinical trials and ensure adequate internal oversight of the scientific aspects of cancer clinical trials with a focus on scientific merit, priorities, and progress following these specific aims: 1) provide clinical protocol scientific review before IRB submission, 2) monitor open clinical trials for ongoing scientific merit and progress, and 3) close trials that fail to meet benchmarks for continued scientific merit and timely accrual. The priority order of clinical trials for are as follows: external peer-reviewed investigator-initiated trials, institutional (investigator-initiated) clinical trials, investigator-initiated industry-supported trials, national (ET- CTN and NCTN) trials, and industry-sponsored trials. PRC/PRMS works in concert with Clinical Protocol and Data Management (CPDM), and the Data and Safety Monitoring Committee (DSMC) to ensure safe and efficient conduct of clinical trials at HCC. The PRC/PRMS role is distinct from the DSMC responsibility of ensuring protocol safety and data quality. The PRC/PRMS also works in conjunction with three other parts of the clinical trials enterprise: the IRB, the UPMC HCC Biostatistics Facility and the UPMC HCC Disease/Modality Center (DMC) teams. The PRC/PRMS has three committees (A, B, and C). Committees A and B alternately review all oncology trials such that one of the Committees meets every 2 weeks to ensure rapid review of studies and facilitate prompt progression of cancer protocols from the PRC/PRMS to the responsible IRB. Committee C reviews biobehavioral, cancer epidemiology, cancer prevention and control, and complementary medicine protocols on an ad hoc basis as required. The PRC/PRMS members are appointed by the HCC Director Robert Ferris, MD, PhD, in consultation with Antoinette Wozniak, MD, HCC Associate Director for Clinical Research. The PRC/PRMS committee consists of representative key academic and clinical faculty from medical oncology, radiation oncology, surgical oncology, pediatric oncology, and also includes biostatisticians, pharmacists, CPDM staff, clinical fellows and basic cancer researchers. Pathologists who are members of our DMC teams may be assigned ad hoc as required. The PRC/PRMS evaluates each protocol for study design, scientific quality, and availability of patient and financial resources required to complete the proposed trial. PRC/PRMS approval of cancer clinical trials is required prior to study submission to the Pitt IRB, NCI CIRB, or other accredited IRBs. Once a trial is opened, the PRC/PRMS reviews its ongoing scientific merit and progress every 6 months. PRC/PRMS has the authority to request explanations for slow accrual and plans to increase accrual from the study PI, allow slow accruing trials t...