ABSTRACT: PROTOCOL REVIEW AND MONITORING SYSTEM The Sidney Kimmel Cancer Center’s (SKCC) Protocol Review and Monitoring System (PRMS) oversees and provides independent peer review of the priority, value, scientific merit, and progress of all cancer studies conducted at Thomas Jefferson University (TJU). A cancer clinical study is defined as a formal research plan with a hypothesis and specific aims intended to evaluate an untested, unproven, or unknown regimen or procedure for the screening, diagnosis, staging, treatment, support, outcome, prevention, control, or characterization of human subjects regarding cancer. Studies undergo a 3-phase review, first at the Multidisciplinary Disease Group (MDG) level, then at the Protocol Facilitation Committee (PFC) and subsequently at the Protocol Review and Monitoring Committee (PRMC) before moving forward to IRB review All cancer research conducted within TJU and the developing regional research sites must be reviewed by an MDG, comprised of voting physicians and investigators who treat a specific disease group. Each MDG crafts disease specific trial portfolios that harmonize with the goals of prioritizing investigator-initiated trials, aligning with the SKCC strategic plan, and serving our catchment area. The SKCC PFC is comprised of Clinical Trials Office (CTO) clinical management as well as finance, regulatory, quality assurance, pathology, nursing, laboratory, radiology, and pharmacy representatives, and is responsible for assessing the logistical feasibility of conducting trials approved by the MDGs. The SKCC PRMC, is comprised of physicians, pharmacists and biostatisticians appointed by the Center Director and administratively supported by the CTO. The PRMC has the ultimate authority and charge to carry out this mandate. The primary responsibility of the PRMS is to ensure that all cancer research studies involving human subjects conducted at SKCC are scientifically and statistically sound, appropriately designed, feasible for completion, contribute added value to the SKCC mission, and monitored regularly for accrual and scientific progress. In addition, PRMS serves to promote and prioritize investigator-initiated clinical research that aligns to SKCC Program priorities and/or research that addresses catchment area needs. The PRMS serves to: 1) Ensure the efficiency and quality of the review processes for cancer clinical research protocols; 2) Prioritize SKCC- developed clinical trials; and 3) Evaluate the progress and scientific impact of ongoing clinical trials. In this cycle, the PRMS has provided the mission-critical, scientific review new clinical research studies and monitored the accrual and scientific progress of all studies.