Protocol Review and Monitoring System (PRMS)

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The goal of the Protocol Review and Monitoring System (PRMS) is to ensure scientific quality and patient safety. The PRMS provides internal oversight of the scientific, research, and resource aspects of all cancer clinical trials at the center. Additionally it is responsible for prioritization of trials. At Stanford, the PRMS consists of two committees: the Scientific Review Committee (SRC) and the Data and Safety Monitoring Committee (DSMC). In the spring of 2004, Susan Knox, Ph.D., M.D. was appointed the Faculty Director of the PRMS and along with Miriam Bischoff, M.S., M.B.A., Facility Director, the PRMS structure, committees, and standard operating procedures were developed. The PRMS provides the administrative infrastructure and its Executive Committee provides the directions for the operations of the two committees. Sandra Horning, M.D., serves as the Chair of the SRC. Robert Carlson, M.D. is the Vice Chair of the SRC. Susan Knox, Ph.D., M.D. chairs the DSMC. She is assisted by Sandhya Srinivas, M.D. Beginning in September 2004, the PRMS received funding from the School of Medicine to hire 2 FTE's; an Administrative Director and an Associate. Partial funding for the Director and Committee Chairs was also provided. The committees, each with its own standard operating procedures (included as an attachment) became operational in April, 2005. The 35-person SRC meets twice per month and reviews all trials that have cancer patients enrolled. All Comprehensive Cancer Center studies are reviewed and prioritized by a disease management group prior to SRC review. Studies can be submitted simultaneously to the Stanford's Administrative Panels on Human Subjects in Medical Research, referred to as the Institutional Review Board (IRB). The PRMS administration works closely with the IRB to assure that all studies are reviewed and approved by both organizations prior to opening the study to accrual. The SRC monitors study accrual and progress on an annual basis. The 18-person DSMC meets once per month to review monitored investigator-initiated studies and adverse event reports. The DSMC can recommend that a study be closed to the SRC. The SRC has the authority to close non-performing studies based upon its review or its agreement with the recommendation of the DSMC.