Clinical Protocol and Data Management

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Clinical Protocol and Data Management (CPDM) ABSTRACT The City of Hope Comprehensive Cancer Center (COHCCC) CPDM provides a centralized, comprehensive infrastructure which supports the conduct of all translational and clinical research. The CPDM encompasses two divisions: (1) Clinical Research Operations and (2) Clinical Research Informatics. The CPDM is led by Dr. Larry Kwak, MD, PhD, Associate Director for Experimental Therapeutic and Translational Research. Clinical Research Operations is led by Ashley Baker Lee, Senior Vice President for Research Operations and is responsible for study activation, education and training, policy and procedure development as well as accruals, data management and quality, and data and safety monitoring. Informatics, which includes Clinical Research Informatics, is led by Sorena Nadaf, Senior Vice President and Chief Informatics Officer and continues to provide support for the centralized systems which house COHCCC protocols (CTOL), clinical trials management system (MIDAS) 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.