CORE--PROTOCOL AND DATA MANAGEMENT

University Of Chicago, Chicago IL

Investigators

Linked publications, trials & patents

Abstract

DESCRIPTION (provided by applicant): The Protocol and Data Management Office (PDMO) of the University of Chicago Cancer Research Center (UCCRC) is a shared resource that provides central management and oversight functions for coordinating, facilitating, and reporting on the cancer clinical trials of the University of Chicago. It interacts closely with the Biostatistics and Information Technology facility (BIT) and the Protocol Review and Monitoring System (PRMS) to maintain high quality data, regulatory compliance, and centralized lists of active protocols with accrual status for use by UCCRC investigators. Dr. Gini Fleming replaced Dr. Everett Vokes as Director of this facility during the past grant period. The specific aims of the PDMO are; to facilitate and coordinate review and approval of protocols by both the UCCRC Clinical Trials Review Committee (CTRC) and the University of Chicago Institutional Review Board (IRB), and maintain records of correspondence with both committees; To monitor data quality and protocol compliance by periodic audits of all in-house protocols; To assure patient safety and regulatory compliance with Federal guidelines for investigational drug use and toxicity reporting through protocol audits and a centralized Adverse Event (AE) reporting system which confirms that all appropriate NCI and other agencies are notified of serious events; To facilitate Federal reporting requirements such as CDUS reports on phase II network trials and annual IND reports; To provide a centralized database of active studies and patients accrued to cancer clinical trials for use by investigators and the PRMS; To provide the centralized regulatory and data management coordination needed for the conduct of studies through a network of affiliated institutions; and To provide training and education to new investigators, nurses, and data management personnel in the technical aspects of clinical research and good clinical practice.