) The Data Management Core at the Moffitt Cancer Center has three main functions: A. Assistance in patient enrollment and treatment on clinical trials B. Clinical trials data management C. Quality assurance of data Clinical trials data management is centrally directed, yet based in the interdisciplinary clinical programs where the DMC staff function as members of the multidisciplinary teams. In addition to the functions noted above, the DMC is responsible for recruitment and training of clinical research staff. Staff assignments are based upon accrual, utilizing a staffing ratio of approximately 40 patient accruals (therapeutic) to 1.0 FTE. Annual patient accrual of the Cancer Center for fiscal year ?99 exceeds 3700, with over 975 patients on therapeutic studies. In addition to CCSG support, the data management core is supported with institutional funds and charge-back revenue from industrial studies and cooperative groups. The Cancer Center has committed substantial support to Data Management functions and the Clinical Trials Finance Office has been successful in recovering significant support from pharmaceutical studies for this purpose. However, institutionally based, peer reviewed studies will continue to grow, especially with the Phase I/II Clinical Research Unit expansion. The increase in patient accrual, especially to innovative phase I/II clinical trials, and the additional burdens of an increasing population to follow requires additional staff. We are requesting a total of 1.35 FTE.
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