ABSTRACT The Protocol Review and Monitoring System (PRMS) at Georgetown Lombardi Comprehensive Cancer Center (LCCC) is operationalized through the Protocol Review and Monitoring Committee (PRMC). The PRMC is responsible for review of clinical cancer research protocols for scientific merit, establishing prioritization of protocols based on scientific impact, alignment with program goals and patient availability. The PRMC oversees all cancer-related clinical research studies at all MedStar (MH) hospitals and the John Theurer Cancer Center (JTCC). The PRMC includes 3 subcommittees. The Population Science Subcommittee, chaired by Suzanne O'Neill, PhD, does initial review of population science studies and studies involving healthy human subjects. The Resource Allocation for Investigator-Initiated Trials (RACIIT) Subcommittee, chaired by Bruce Cheson, MD, allocates CCSG and institutional funds to support IITs and the Scientific Progress Review Subcommittee (SPRC), chaired by Michael Atkins, MD, monitors scientific progress. Changes since the last review include: 1) the incorporation of JTCC clinical research into the PRMS in September 2015; 2) Al-Refaie stepped down as co-chair in 2015 and was replaced by Giaccone and Rowley; 3) investigators from JTCC were appointed to the PRMC as well as all subcommittees; and 4) implementation of the ePRMS module in OnCore for submissions from LCCC and other MedStar sites in 2017, with plans to extend functionality to JTCC in 2018.The PRMC is comprised clinical investigators from multiple MH hospitals and JTCC, biostatisticians, basic scientists, population scientists, and translational researchers. Claudine Isaacs, MD, a medical oncologist and a breast cancer clinical investigator, has been Chair of the PRMC since 2006. Giuseppe Giaccone, MD PhD, Associate Director for Clinical Research, assumed a co- chair position in 2015, and Scott Rowley, MD, a hematologist oncologist with expertise in stem cell transplant and cellular therapy, was appointed co-chair in 2017. The PRMC reviewed and/or prioritized 565 clinical trials over the past 4 years; 228 were deferred for revisions and ultimately approved following further revisions; 3 were disapproved in initial review, and 13 studies were withdrawn by investigators based on the PRMC review. In addition, 24 letters of intent for investigator-initiated trials were reviewed, of which 14 were approved for protocol development, eight required revisions prior to approval and two were withdrawn after PRMC feedback. The SPRC reviewed 576 studies; 313 were approved for continuation, 190 required revision and re- review in six months and 73 studies were closed. RACIIT reviewed 12 requests for funding and/or clinical research management office staff support, approving 10 of these requests.