Protocol Review and Monitoring System

The primary responsibility for the Protocol Review and Monitoring System (PRMS) rests with the University of Michigan Health Rogel Cancer Center (Rogel) Protocol Review Committee (PRC). The PRC is aided in its pursuit of the PRMS Specific Aims by the Clinical Research Teams (CRT) which have specific, nonoverlapping, and well-defined roles. All cancer protocols undergo two-stage review, starting with the CRT review and the culminating with PRC review. CRTs are disease- and domain-oriented groups in the Rogel that serve as the nidus for patient-oriented research. CRTs are led by mid-career and senior clinical investigators who have an academic primary focus on clinical research, have significant experience as principal investigators on interventional cancer clinical trials (with particular emphasis on investigator-initiated trials), and see patients in the clinics associated with their respective disease team. The CRTs are charged with reviewing and prioritizing proposed cancer clinical trials within their respective disease/domain that arise from the scientific themes in the Rogel Programs and elsewhere, both to ensure scientific merit, and to increase the chances of success in implementation. The PRC, which is comprised of experts in clinical research from a range of disciplines, provides independent peer review of the scientific merit and feasibility of new cancer-related clinical protocols. It also monitors the scientific progress of activated protocols to ensure that they continue to be of high scientific merit and priority, support the Rogel research mission, and achieve accrual goals in a realistic timeframe. By providing this level of exceptional peer-review oversight of cancer clinical research, PRMS helps to ensure that Rogel conducts high quality protocols that are scientifically impactful, realize their accrual targets, and utilize Rogel resources wisely.