PROTOCOL REVIEW AND MONITORING SYSTEM (Core-016)

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CORE: Protocol Review and Monitoring System (PRMS) PROJECT SUMMARY The Dan L. Duncan Cancer Center (DLDCC) has established the Protocol Review and Monitoring Committee (PRMC) to provide systematic internal oversight of the scientific and research aspects of all cancer-related therapeutic and prevention clinical trials conducted in DLDCC affiliated institutions. By BCM and DLDCC policy, the PRMC has authority to approve and close all DLDCC clinical research protocols. Chaired by Stacey Berg, M.D., the PRMC is organized into an Executive Committee and three working groups, with a total of 44 voting members. The PRMC assigns each protocol a scientific merit score of 1-9 according to standard NIH review descriptors. In addition, a DLDCC 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 (CTEP) 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. The PRMC also monitors progress and accrual of active studies. At the time of each open protocol’s annual IRB review, or more frequently if deemed necessary, the PRMC conducts a full review to ensure that adequate scientific progress is being made. In addition, the PRMC reviews the accrual to all the open protocols in each Program on a quarterly basis. The PRMC functions in a complementary but not duplicative way with the IRB and the Data Safety Monitoring Committees. The PRMC provides reports to the Clinical Research Leadership Committee, which also receives reports from the Data Safety Monitoring Committees, thus ensuring that activities of these two separate entitles are integrated. From 2011 to 2013, the PRMC reviewed an average of 44 new submissions per year, including 10 investigator-initiated institutional, 19 National Group, 3 other externally peer reviewed, and 12 industry sponsored protocols. An average of 140 annual reviews of ongoing progress were also performed each year.