Protocol Review and Monitoring System

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PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) PROJECT SUMMARY The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) at Baylor College of Medicine (BCM) has established the Protocol Review and Monitoring Committee (PRMC) to provide systematic internal oversight of the scientific and research aspects of all interventional cancer clinical protocols conducted in DLDCCC institutional facilities. By BCM and DLDCCC policy, the PRMC has authority to approve and close all DLDCCC clinical research protocols. Chaired by Stacey Berg, MD, the PRMC is organized into an Executive Committee and 3 Working Groups, with a total of 49 members. The PRMC assigns each protocol a scientific merit score of 1–9 according to standard NIH review descriptors. In addition, a DLDCCC priority score of High, Medium, or Low is assigned to aid protocol prioritization. Studies that have been approved by the NCI Cancer Therapy Evaluation Program or Cancer Prevention and Control Protocol Review Committee, or that are supported by an NIH funding mechanism that required full peer review as part of the funding process undergo an expedited administrative review. In addition, for multi-site institutional trials, the protocol may be eligible for expedited PRMC review if BCM is not the lead site and the approved PRMS of the lead site has performed full scientific review of the protocol. The PRMC also monitors progress and accrual of active studies. At the time of each open protocol's annual IRB review or more often if deemed necessary, the Executive Committee conducts a full review to ensure that adequate scientific progress is being made. In addition, the Executive Committee reviews the accrual to all open protocols in each Program on a quarterly basis. Protocols whose accrual continues to lag are subject to closure by the PRMC, as are protocols whose scientific goals may have been superseded by developments in the field. PRMC review complements, but does not duplicate, IRB or Data Safety Monitoring Committee review. From 2016 to 2018, the PRMC reviewed an average of 64 new submissions per year, including 10 DLDCCC investigator-initiated institutional, 27 National Group, 2 other externally peer reviewed, and 17 industry- sponsored protocols. In addition, an average of 226 progress reviews and 27 amendment reviews per year were also performed.