Core 017 (502) Protocol Review and Monitoring System

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PROJECT SUMMARY The MCC Protocol Review & Monitoring System (PRMS) provides internal oversight of the scientific aspects of all clinical trials. This includes full authority for opening, closing, and determining appropriate prioritization of all studies. To conduct PRMS processes, MCC utilizes four Scientific Review Committees (SRCs) supported by staff coordinators. The PRMS has processed more than 500 protocols for initial review over the past three years. The average time from submission to full board review is approximately 20 days. Committee coordinators review the materials submitted for completeness and work with the study team to acquire any additional information needed for the scientific review process. Upon review of the complete information package (protocol, investigational brochure, and surveys), the coordinator evaluates the protocol to determine if it qualifies for expedited review or requires a full SRC board review. If the coordinator believes the study qualifies for expedited review (e.g., NCI, NCTN, or ETCTN), the coordinator routes the study for confirmation and approval. If the study requires a full board review, the coordinator will schedule the study on the next available open agenda. The four SRCs have meetings scheduled throughout the month to ensure a timely review. The PRMS also reviews all amendments to studies. Amendments that change study objectives, outcome measures or the study population, and other major changes are sent to full SRC board for review. The PRMS processed over 500 amendments to studies in FY15 with 100 requiring a full SRC board review. The PRMS is also responsible for monitoring the scientific progress of all MCC studies. Studies are monitored at each six-month anniversary of their activation date. Those studies that significantly fall below their anticipated accrual rate are flagged for discussion at the full SRC board. At that time, the board reviews the progress of the study and also the explanation and corrective action plan from the PI to determine if the study is likely to meet its accrual goal. If the SRC determines the study will not meet the accrual goal or is no longer scientifically important, then the study is closed by the SRC. The specific aims of the PRMS are as follows: • Aim 1: Establish and maintain a review committee of sufficient size and breadth of expertise to conduct a critical and fair scientific review of cancer-related research protocols involving human subjects • Aim 2: Conduct a thorough scientific review of all cancer-related clinical protocols conducted at the MCC based on specific, pre-determined review criteria • Aim 3: Prioritize all MCC clinical trials • Aim 4: Monitor scientific progress for ongoing clinical trials