CORE--CLINICAL RESEARCH OFFICE

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The purpose of the Clinical Research Office (CRO) is to provide central management and oversight functions for coordinating, facilitating, and reporting on the cancer clinical research of the center, whatever the origin. The CRO accomplishes this purpose by providing the following services to Mayo Clinic Cancer Center (MCCC) investigators: 1) Protocol development and maintenance support, 2) Regulatory support, 3) Data systems management, 4) Quality control, 5) Operational support, and 6) Information systems. With centralized services, the CRO provides a stable and efficient administrative structure to coordinate these activities across the entire scope of the MCCC, including phase I-III clinical trials, pilot studies, and population-based studies. The Clinical Research Office previously functioned as part of the Mayo Clinic Cancer Center Statistics Unit Shared Resource. This shared resource was comprised of two units - the Statistics Unit and the Research Support Services Unit. Due to the recent significant expansion in scope and increase in regulatory burden, the two units have now separated, forming the Biostatistics Shared Resource and the Clinical Research Office. The CRO supports clinical trials and non-interventional population-based clinical research that are supported by one or more of the following: ? Peer-reviewed extramural funds (NIH, DoD, etc.), ? Mayo Clinic Cancer Center (including CCSG) ? Phase land Phase II (NCI, U01, N01) ? NCI Cooperative Group and CCOP Programs (MCCC is the research base of the North Central Cancer Treatment Group (NCCTG) and a member of ECOG, RTOG, GOG, ACoSOG, and COG) ? Industry funds The ability to use the same database for all studies and to configure tables, interfaces, and reports to meet program or protocol specific needs, allows the systems and procedures to be consistent between all sponsors and programs. This consistency fosters efficiency and programmatic operational synergy.