The Protocol Review and Monitoring System (PRMS) oversees and ensures the scientific merit, appropriate resourcing and progress of all clinical studies at KUCC. KUCC received conditional approval of PRMS at the 2012 NCI site visit and have made multiple personnel and process changes since that time resulting in full approval in August 2016. The KUCC Clinical Trials Office (CTO) may support the Center's cancer clinical trials that are approved by the PRMS. The PRMS evaluation occurs prior to submission to the institutional review board called the Human Subjects Committee (HSC) and does not overlap with HSC responsibilities. The three components of the PRMS are the Disease Working Groups (DWG; reporting to Associate Director (AD) of Clinical Research; Carol Fabian, MD, 2016), the Executive Resourcing Committee (ERC; Stephen Williamson, MD, Chair, 2013, also reporting to AD of Clinical Research), and the Protocol Review and Monitoring Committee (PRMC; Qamar Khan, MD, Chair 2013, reporting to the Deputy Director). Although each component has a unique role, these are aligned to ensure protocols are efficiently moved through the system, receive high-quality peer-review and monitoring, and that the research portfolio is consistent with KUCC clinical research priorities. The DWGs, which meet monthly, are charged with initial review of clinical trial merit and feasibility, and with prioritizing by disease-site. Highest priority is given to investigator initiated peer-reviewed funded trial proposals. DWG co-chairs are appointed by the AD for Clinical Research. Although the DWG composition is rich in clinicians focused on treatment trials and primarily D3ET members, representatives of CPS and CCPH are also DWG members. DWGs with significant prevention and survivorship components have formal liaisons from CPS and CCPH, and this is likely to extend to CB in the future. To further increase interaction with KUCC programs and translational research, each DWG has one of their meetings per year replaced by a Clinical Translational Research Meeting focused on their area but chaired by the AD of Clinical Research with at least 1 basic or behavioral scientist presenting a relevant proposal or ongoing project along with 1-2 clinical projects. All KUCC members are invited and KUCC program leaders and ADs are expected to attend. DWGs are evaluated yearly by the AD for proportion of trials that are IIT and/or national, quality and translational nature of interventional trials, trial accrual, and national meeting presentations and publications. The ERC reviews protocol resource requirements, available funding, and alignment with KUCC research programs as defined by the Leadership Council (ADs and Program Leaders); CTO sends ERC approved studies to the PRMC for Scientific Review. The PRMC performs independent scientific merit and bio-statistical reviews, including rationale, design, statistical analysis plan, and adequacy of the data safety monitoring. The PRMC also monitors active protocols at least annually for continued scientific merit, clinical appropriateness, progress toward completion of scientific objectives, accrual status, and terminates studies as appropriate.
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