Clinical Protocol and Data Management

PROJECT SUMMARY/ABSTRACT The Perlmutter Cancer Center (PCC) Clinical Protocol and Data Management Core (CPDM) standardizes, manages, and reports on all cancer-related human subjects research across the NYU Langone Health (NYULH) network. CPDM also delivers education and training services for research professionals, provides monitoring and auditing functions, and ensures the efficient and compliant conduct of cancer clinical research. CPDM functions are provided through the PCC Clinical Trials Office (CTO) for research activity on the PCC Manhattan, Long Island, and Brooklyn campuses. The Associate Director for Clinical Research, Janice Mehnert, MD, provides oversight for the CPDM. The CTO employs a total of 178 staff and is led by Administrative Directors for Clinical Operations and Data Management/Regulatory Affairs, who report to Medical Directors from the Manhattan and Long Island campuses. The CTO research staff facilitate clinical research by the 14 Disease Management Groups (DMGs) at PCC, carry out monitoring activities for the PCC Data Safety and Monitoring Committee (DSMC), and support review activities for the PCC Protocol Review and Monitoring Committee (PRMC). The CTO manages clinical research informatics, maintains a central repository for all protocols, regulatory documents, consent forms, and data for individual studies, provides a web-based listing of current clinical studies at PCC, and informs PCC faculty at all locations, including satellites, of open clinical trials. The CTO also ensures adherence to local and federal regulations and NYU Langone Health clinical research policies. During the current funding period, we expanded our clinical research infrastructure to support clinical trials across the PCC network in Manhattan and Long Island and initiated clinical research activities in Brooklyn. We developed a Study Activation Task Force to address activation timelines that had lengthened during the COVID- 19 pandemic (resulting in a decrease of time-to-trial-activation to 75 days), increased support for the development and activation of investigator-initiated trials, and initiated efforts to improve the accrual of patients from lower income populations to clinical trials. These activities have increased the accrual of patients to clinical trials at PCC and improved the quality, complexity, and impact of CPDM-supported clinical cancer research.