PROTOCOL DATA

University Of Nebraska Medical Center, Omaha NE

Investigators

Linked publications & trials

Abstract

The Centralized Protocol and Data Management Unit (CPDMU) is a Cancer Center Shared Resource widely used by members performing clinical and translational trials. The CPDMU, which was formerly known as the Clinical Trials Office at the last CCSG review, plays a central role in clinical/translational research in the Cancer Center. The primary mission of the CPDMU is to provide the necessary components and support to conduct high-quality clinical cancer research at the Cancer Center at the University of Nebraska Medical Center, as well as UNMC affiliated hospitals (The Nebraska Medical Center, Children's Hospital Medical Center, Veterans Administration Hospital), and at Cancer Center Affiliate sites across the state. The CPDMU provides a centralized resource to facilitate the development, conduct, quality assurance monitoring, compliance with regulatory agency requirements, and evaluation of clinical research at the Cancer Center. All cancer related research proposals flow through the protocol development process established and administered by the CPDMU and are subsequently sent for review to the Protocol Review and Monitoring System (PRMS), the PRMS Scientific Review Committee (SRC) and to the IRB. The CPDMU database of clinical trials also provides support for the PRMS SRC and Audit Committee (AC) and for the Data and Safety Monitoring Committee (DSMC).