CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) In order to facilitate and standardize the human subjects research infrastructure at the Laura and Isaac Perlmutter Cancer Center (PCC), a centralized Clinical Protocol and Data Management Core (CPDM) promotes, supports, and monitors all cancer-related human subject research. In the current funding period, we substantially upgraded and expanded the organizational structure at PCC to provide improved integration and coordination of our clinical cancer research. The CPDM at PCC, known internally as the Clinical Trials Office (CTO), provides central management and oversight functions to coordinate, facilitate, and report on cancer clinical trials at PCC. The CTO provides support for the Center?s Disease Management Groups (DMGs), its Protocol Review and Monitoring Committee (PRMC), and the Data and Safety Monitoring Committee (DSMC). Members of CTO subunits (described herein) provide infrastructure support to the PRMC at the pre- and post- activation stages. The CTO also manages the clinical research informatics technology, 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. Quality assurance functions of the CTO include education and training, monitoring, auditing, and other compliance measures to ensure patient safety, data timeliness and accuracy. The CTO also ensures adherence to local and Federal regulations and NYU Langone Health clinical research policies.
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