The Clinical Investigations Support Office (CISO) serves as a centralized unit to oversee the clinical research infrastructure and assist investigators in their conduct of clinical trials and translational research projects. CISO has been reorganized following recommendations of an external advisory group and the Cancer Center Executive Committee and with the concurrence of the NCCC External Advisory Committee. The 58 personnel are now located in 15 of newly remodeled contiguous offices in the Ezralow Tower of the Cancer Center. CISO has three main operational units: 1) Protocol Administration; 2) Protocol Implementation; and 3) Administrative/Business Management. The Protocol Administration Unit provides the centralized consultation and regulatory services necessary for the design, initiation, and conduct of externally-funded and internally peer-reviewed and monitored clinical trials. The Protocol Implementation Unit provides the centralized function of advising and assisting investigators in patient eligibility assessments, patient recruitment, data quality control and oversight. The Administrative/Business Management Unit was recently created in 2007 in order to coordinate CISO's relationships with institutional entities outside the Cancer Center and with sponsors. It is also charged with assisting the various investigators and sections to manage their funding sources, allocate their financial and human resources in an efficient manner, and be able to make sound projections for future growth. In addition to the services provided by the three operational units, CISO plays a central coordinating role within the Cancer Center through its interactions with other cores such as the Biostatistics Core, the Cancer Research Informatics Core (CRIC), the Translational Pathology Core, and the Protocol Review and Monitoring System entities (Clinical Investigations Committee and the Quality Assurance and Monitoring Committee). The Cancer Center Executive Committee exercises full authority over CISO policies and resource allocation and reviews the CISO's performance on a biannual basis.
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