Clinical Protocol and Data Management

Rbhs -Cancer Institute Of New Jersey, New Brunswick NJ

Investigators

Linked publications, trials & patents

Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY/ABSTRACT The purpose of the Office of Human Research Services (OHRS) is to enable and enhance clinical and translational research across the consortium by providing Rutgers Cancer Institute of New Jersey (CINJ) members with centralized resources, information and expertise in clinical research. OHRS has the responsibility of working with clinical investigators to manage the business, clinical and regulatory functions of all phases of pediatric and adult interventional/non-interventional trials at CINJ. The current organizational structure is comprised of approximately 70 FTEs and six functional offices including clinical operations, quality assurance, and regulatory affairs. The activity and use of OHRS parallels the growth of the center and has increased as the number of CINJ investigators and oncology faculty increased. In the most recent grant period (2011-2017) the OHRS managed enrollment of 26,432 patients, compared to the seven-year interval corresponding to the previous grant period (2004-2010) in which 11,454 patients were enrolled. Currently, there are 154 active enrolling trials (92 therapeutic) supported by the OHRS. Given an overall Center initiative to enhance translation of center science, OHRS has increased its support for investigator-initiated and multi-center trials and continues to be used extensively by CINJ members.