Clinical Protocol and Data Management

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) PROJECT SUMMARY/ABSTRACT Rutgers Cancer Institute had an unprecedented opportunity to expand clinical research to a significant number of RWJBarnabas Health (RWJBH) system hospitals thanks to 1) Dr. Libutti’s roles as Cancer Center Director and Senior VP for Oncology Services of RWJBH; 2) Dr. Hochster’s roles as Cancer Center 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. Rutgers Cancer Institute’s 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. CPDM’s goal is to enable and enhance clinical and translational research by providing centralized resources, information, and clinical research expertise. All oncology research at all RWJBH hospitals and RU sites was consolidated under OHRS’s direction and management with single PRMS oversight. Through comprehensive planning, in conjunction with COE, intentional and strategic network growth brought clinical trials to populations and geographic areas facing higher or otherwise significant cancer burden. In this newly integrated and unified “one-site” model, CPDM has access to unprecedented numbers of patients for clinical research activities to address catchment area priorities and needs. OHRS serves as a centralized clinical research administration, housing all administrative tasks at Rutgers Cancer Institute while providing oversight and direction for each clinical oncology research operation site. OHRS has the responsibility of working with Rutgers and RWJBH clinical investigators to manage the business, clinical and regulatory functions of all phases of cancer clinical trials. The organizational structure comprises 196 FTEs with ten distinct offices based on specialization within functional areas. OHRS activity increased along with the number of research operation sites, clinical trials, and investigators. Following an “exceptional to outstanding” in the last review, OHRS was enhanced by increased staff, full implementation of OnCore® clinical research management system software, and systems for system-wide clinical trials. These include global OnCore® access, use of eREG application for online DOAs access, 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. Since the last review, open treatment trials more than doubled and enrollment to therapeutic treatment trials increased 80% with a 300% increase in enrollment from RWJBH sites.