CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) PROJECT SUMMARY/ABSTRACT In this grant cycle, Rutgers Cancer Institute of New Jersey (CINJ) had an unprecedented opportunity to expand clinical research to a significant number of additional hospitals of the RWJBarnabas Health (RWJBH) system. This unified and organized expansion was enabled by 1) Dr. Libutti’s roles as Cancer Center Director and Senior VP for Oncology Services of RWJBH; 2) Dr. Hochster’s roles as CINJ Associate Director for Clinical Research and Director of Oncology Research for RWJBH; and 3) development of a system-wide academic health system between Rutgers and RWJBH effective 01/01/2019 through a Master Affiliation Agreement. The CINJ Office of Human Research Services (OHRS) was established to meet the current and future needs of Cancer Center Members and other stakeholders in the broader university and hospital community. The goal of this CPDM resource is to enable and enhance clinical and translational research by providing CINJ members with centralized resources, information, and expertise in clinical research. All oncology research at all hospitals and sites of RWJBH and RU have been consolidated under the direction and management of the OHRS with single PRMS oversight. Through comprehensive planning, and in conjunction with Community Outreach and Engagement (COE), network growth was intentional and strategic to bring clinical trials to underrepresented populations. In this newly integrated and unified “one-site” model, CPDM has access to unprecedented numbers of patients for clinical research activities to positively impact catchment area priorities and needs. OHRS serves as a centralized clinical research administration, housing all administrative tasks at CINJ while providing oversight and direction for each clinical oncology research operation site throughout RWJBH. OHRS has the responsibility of working with both Rutgers and system-wide clinical investigators to manage the business, clinical and regulatory functions of all phases of pediatric and adult oncology cancer clinical trials throughout the health system. The organizational structure comprises 196 FTEs with ten distinct offices based on specialization within functional areas such as clinical operations, quality assurance, and regulatory affairs. OHRS activity increased along with the number of research operation sites, clinical trials, and investigators. Following a rating of exceptional to outstanding in the last review, OHRS was enhanced by increased staff, full implementation of OnCore® clinical research management system software (Advarra EDC, eREG, and Insights), and systems for supporting system-wide clinical trials. These include global access to OnCore®, the use of eREG application for online access to DOAs, and global use of the Rutgers eIRB system for investigator registration and compliance. Screening, enrollment, and available clinical trials increased significantly with the integration of RWJBH sites. S...