Protocol Review and Monitoring System

13.0 Abstract: Protocol Review and Monitoring System The Protocol Review and Monitoring System (PRMS) of UMGCC is embodied in the UMGCC Clinical Research Committee (CRC). The CRC reviews all new cancer-related protocols for scientific merit, methodology, competing studies in the portfolio, and reasonability of accrual goals before submission to the UMB Institutional Review Board (IRB). The CRC ensures that expert biostatistical review of clinical trial design and calculation of sample size occurs for each institutional protocol and selected noninstitutional protocols. The CRC provides initial review of the intended data safety monitoring plan and, as needed, verifies PI determinations of research versus standard-of-care procedures. The CRC receives input from Disease Group leaders and the UMGCC Protocol Feasibility Committee to ensure proper prioritization of new and existing protocols. The CRC reviews accrual to all studies supported by UMGCC on a continuous basis and oversees the development of corrective action plans or closes poorly accruing trials. Finally, the CRC provides scientific review as needed for issues that may arise relating to accrual, for safety or adverse events noted by the Data Safety Monitoring/Quality Assurance Committee, or for specific questions referred from the IRB. As of January 2015, with the coalescence of the UMGCC PS Program, individuals with expertise in population science have been recruited as members of the CRC and a process for review of interventional trials from PS members at UMCP and UMB developed. During CY2014, the CRC reviewed at full committee level 63 protocols; 29 were approved as written, 23 were approved with minor modifications, 10 were approved with major modifications requiring re-review, and 1 was deferred. An expedited review process exists for minimal risk studies, and it was utilized to approve 45 studies in CY2014. During CY2014, 83 trials were monitored for accrual, targeting for corrective action any protocols that were not accruing at a rate suggesting successful completion within a 3- to 5-year timeframe. Twenty- three warning letters were issued, resulting in closure of 12 protocols by August 26, 2015.