Clinical Research Support Services (CRSS) support clinical investigations in the development and implementation of clinical trials at Moffitt Cancer Center by: 1) Supporting clinical investigators in screening and enrolling patients onto clinical trials;2) Providing Data Management support for clinical trials;3) Providing staff training and education pertaining to clinical trials;4) Coordinating and implementing protocolrelated orders for study patients;and 5) Preparing medical records for audits. CRSS provide data management support to 17 disease-specific divisions and Lifetime Cancer Screening and Prevention Center, the locus for cancer control and prevention studies/trials. The majority of these investigators are in the Experimental Therapeutics Program, while the remaining are in the Cancer Prevention &Control Program. The CRSS employs approximately 60 staff members to support 70 faculty. Protocol activation and implementation is coordinated via a partnership between the Protocol Review &Monitoring Systems/Scientific Review Committees (PRMS/SRC) and CRSS staff. CRSS staff work with investigators to: acquire the protocol and investigator brochure (if appropriate), complete process flow paperwork, and acquire appropriate institutional signatures prior to PRMS/SRC submission. CRSS staff acts as a liaison between the sponsor and institution to provide relevant information to both parties. Staff work closely with a clinical trials specialist in the sponsored research division to help create the study budget and provide feedback as to standard vs. non-standard of care charges. All clinical research protocols that accrue patients or utilize patient tissue/blood/bone marrow require operational review. CRSS are responsible for ensuring eligible patients are enrolled onto approved clinical trials. CRSS utilizes Clinical Trials Coordinators to: actively screen and evaluate new patients as potential study candidates, coordinate patient enrollment, and work with investigators and patients during informed consent. Data management is available for investigatorinitiated, cooperative group and industry-sponsored trials. Data collection, transcription and submission are the responsibility of the clinical trials coordinator assigned to the clinical division. Since few protocols use computer data entry/remote data retrieval, most studies require data transcription and hard copy submission. Clinical coordinators are instrumental in developing appropriate and adequate data collection tools. CRSS staff are responsible for tracking the required forms for active trials in their corresponding programs. Oncore? clinical trials management system is a comprehensive solution for managing all aspects of clinical research. Oncore? enables the staff to track all protocols from initial scientific review through IRB approval and activation, and provides data for ongoing monitoring until final closure. The system is currently being installed at the Cancer Center and will be live within several months
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