PROTOCOL - SPECIFIC RESEARCH SUPPORT

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PROJECT SUMMARY (See instructions): Moffitt Cancer Center has maintained a focused effort to increase the number of investigator-initiated early phase clinical studies. In 2010, investigators at Moffitt Cancer Center enrolled 354 patients on phase I or l/ll studies. Moffitt remains focused on investigator-initiated studies as a high priority. Services include protocol initiation, activation, coordination and administration, as well as coordination of study-related patient care and data collection. More specifically, the duties and functions of the clinical research coordinators, requested for this Protocol-Specific Research Support Core Facility, will be to coordinate phase I and pilot study clinical trials, including assisting with determining patient eligibility and registration and coordinating protocol-related care of patients enrolled on clinical studies. The research coordinator ensures completion of patient assessments for adverse event and toxicity grading, thorough documentation of all patient observations, and appropriate patient followup according to protocol design. The research coordinator is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by Federal regulations. As the primary resource for the protocols, the research nurse/coordinator acts as liaison between investigators, primary care providers, Moffitt regulatory staff, and the sponsor. Along with the investigator, the research coordinator will screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. The Core requests CCSG Support of $137,864 for support of four research nurses totaling 2 FTEs.