Clinical Protocol and Data Management Core

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Clinical Protocol & Data Management PROJECT SUMMARY Clinical Protocol & Data Management (CPDM) functions at Moffitt Cancer Center (MCC) include 1) trial design, development, and conduct; 2) oversight of safety and compliance; 3) ensuring data quality and education of personnel; and 4) appropriate accrual of women and minorities. A collaborative team of approximately 190 CPDM professionals provides centralized management and support of all types of clinical trials, including investigator-initiated (IITs), industry or other sponsor-initiated, Experimental Therapeutics Clinical Trials Network (ET-CTN), and National Clinical Trials Network (NCTN). CPDM support for members includes: protocol development; budget development and contracting; regulatory and IND/IDE management; protocol activation; patient enrollment; coordination of study-related patient care; research drug administration and care services; correlative science (pharmacokinetics/pharmacodynamics) sample coordination; data collection and reporting; monitoring of IIT studies and data and safety monitoring through the Protocol Monitoring Committee (PMC) and Data Safety & Monitoring (DSM) Committee; audit preparation and coordination; minority outreach and navigation for accrual to clinical trials; clinical trials management system (CTMS, OnCore) administration and reporting; staff workload management; and staff education and training. During the review period (FY2011-2015), the CPDM team successfully accrued and coordinated a combined total of 11,851 patients to clinical interventional trials (therapeutic, prevention, and supportive care), including accrual at affiliate sites. CPDM provides centralized safety and compliance oversight to members through timely monitoring of investigator-initiated interventional trials, coordination of the PMC, and corporate compliance audits of MCC clinical research trials, policies, and processes. Results of monitoring and audits are utilized by the PMC for comprehensive review. MCC has developed and maintains proactive efforts to provide programs and services to women, minorities, and other underserved populations through culturally and linguistically relevant care, education, and internal and community outreach. Faculty members conduct research on minority health disparities, informing these programs and services. In addition, the ACD for Clinical Science and the VP of Diversity and Community Relations co-lead a multi-disciplinary Minority Clinical Research Committee to address issues related to minority accrual at MCC. CPDM resources are closely integrated in these efforts.