Clinical Protocol and Data Management

Abstract Clinical Protocol and Data Management The City of Hope Comprehensive Cancer Center (COHCCC) Clinical Protocol and Data Management (CPDM) provides a centralized, comprehensive infrastructure which supports the conduct of all translational and clinical research. The CPDM is led by Dr. Marwan Fakih, MD, Interim Medical Director for Clinical Trials Office. Dr. Fakih is supported by Alex Hererra, MD, Associate Medical Director for Clinical Trials Office and Ashley Baker-Lee, Associate Director, Administration. Dr. Fakih is responsible for study activation, education and training, policy and procedure development, accruals, data management and quality as well as data and safety monitoring. This includes the teams who support the centralized systems, including the clinical trials management system (OnCore) and case report form development (Medidata Rave). The CPDM provides a strong foundation for high-quality clinical research by ensuring quality design of COH initiated research, efficient study start up, accurate collection of data to meet protocol objectives, protocol compliance, and monitoring trial conduct and progress. As a centralized and integrated resource, CPDM provides dedicated and experienced staff to support COH’s robust and growing research portfolio.