A major goal of Huntsman Cancer Institute (HCI) is to conduct a vibrant clinical research program, providing a portfolio of scientifically excellent clinical trials for our patients, support for the clinical research efforts of our faculty, and improved strategies for cancer detection, diagnosis, treatment, and prevention through our clinical research activities. As an NCI-designated Cancer Center with a strong foundation in cancer-focused research, we have both an opportunity and a responsibility to translate our discoveries to impact patient care. To achieve this objective, we must have in place a robust Protocol Review and Monitoring System (PRMS) to review the scientific merit of proposed clinical studies, evaluate the contribution of proposed protocols to the strategic aims of our Cancer Center, and assess the scientific progress of ongoing studies. When Dr. Beckerie was appointed Executive Director of HCI in August 2006, our PRMS faced significant challenges. The HCI PRMS had been disapproved at the time of our 2003 competing review. Although reevaluations in 2004 and 2005 recognized evidence of improvement, the review teams noted ongoing deficiencies. Dr. Beckerie highlighted the critical need for excellence in our institutional PRMS, developed a step-wise approach to analyze and improve the PRMS with internal analysis, multiple external Cancer Center consultants, HCI site-visits to other Cancer Centers, and input from our External Advisory Board. By integrating these recommendations, substantial changes to our PRMS were made. HCI's PRMS was formally reviewed and unconditionally approved by NCI in December 2008. PRMS functions at HCI are fulfilled by the Clinical Cancer Investigations Committee (CCIC). The CCIC: 1) conducts thorough scientific review of all cancer-related studies performed at HCI, 2) prioritizes research protocols and prevents protocol competition, 3) prioritizes protocols for access to HCI Clinical Trials Office support, 4) evaluates ongoing protocols for continued progress toward accrual goals, 5) reviews and approves protocol amendments, and 6) closes under-accruing trials. Before a study can be presented to the CCIC, it must be submitted to the appropriate multidisciplinary disease group for review, approval, and priority rating. CCIC protocol review follows a standardized format in which reviewers are tasked to respond to a set of review criteria; an electronic management and notification system aids in the PRMS process. The CCIC has broad and extensive expertise in oncology to ensure that clinical protocols and assessment of progress are reviewed at a high scientific level, including representatives from Medical Oncology, Surgical Oncology, Pediatric Hematology-Oncology, Radiation Oncology, Nuclear Medicine, Biostatistics, Pharmacology, Pathology, Basic Science, and Population Science, Research Nursing, and a Patient Advocate, as well as HCI's Executive Director Mary Beckerie, PhD, and Scott Lloyd, MBA, Senior Director of Administration and Finance, as ex-officio members.

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