ABSTRACT: CLINICAL PROTOCOL & DATA MANAGEMENT The overall goal and objective of the Sidney Kimmel Cancer Center Clinical Trials Office (CTO) is to ensure that patients have access to a wide range of novel clinical trials which will improve the lives of cancer patients. There are over 150 open to accrual oncology clinical trials being conducted within the center at any one time and the CTO is the arm of the SKCC that manages and supports this important work. It ensures that trials comply with all federal, state and institutional regulations and provides an effective, efficient, centralized infrastructure to support SKCC investigators in developing, implementing, and reporting on all cancer clinical research studies across the Jefferson Health Enterprise. There over 151 staff members in the CTO that that provide regulatory support, clinical trial coordination, data management, monitoring, quality assurance, training/education and clinical trial recruitment/engagement. The Senior Executive Director (Kristin Herman, MBA) oversees the CTO who reports to the Vice President and Associate Director for Cancer Research Administration (Matthew Huesser, MBA, DBA), Vice President of the Cancer Services (Alex Khariton, MBA), and Associate Director for Clinical and Translational Research (Wm Kevin Kelly, DO) all under the direction of the SKCC Center Director, Dr. Andrew Chapman, DO. The CDPM functions are supported by the Clinical Trials Office (CTO). The CTO is made up five units with well-defined roles and responsibilities: (1) Cancer Clinical Research Operations (CCRO) oversees the multidisciplinary disease teams conducting Phase II and III studies; (2) Early Phase Research Operations (EPRO) oversees most complex early Phase I studies; (3) Community Research Operations and Enrollment (CROE) oversees community research, screening for trials, and other recruitment services, working closely with the AD of COE; (4) Research Support Services (RSS) provide regulatory support for clinical trials, maintain data quality and reporting oversight via OnCore CTMS, and provide the coordination of the Protocol Review and Monitoring Committee (PRMC); (5) Quality Assurance and Education Unit (QAE) dedicated to the management of the Center’s Data Safety Monitoring (DSM) functions and CTO staff training.