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The UC Irvine Chao Family Comprehensive Cancer Center's Stern Center for Cancer Clinical Trials & Research is composed of three units:
All three units provide a centralized mechanism to support cancer clinical research and enhance the ability of CFCCC members to conduct clinical studies in compliance with all federal and state regulatory requirements. The Stern Center directly facilitates and supports the conduct of cancer treatment clinical trials for the entire lifecycle of a research study, which includes development and implementation support, as well as quality control functions. In addition to assistance specifically related to the planning and conduct of study protocols, Stern Center staff work closely with the School of Medicine and with Clinical Informatics to team-manage the clinical trials management system, OnCore, which houses protocol-specific data necessary for planning, reporting, and internal oversight, as well as tracking of activities, workloads and other key metrics.
The CTU provides central management and oversight assistance for coordinating and facilitating the study management needs for cancer clinical trials for the CFCCC. Clinical research coordinators (CRCs) are assigned to one of three teams who each handle several disease sites. Accordingly, CRCs work with multiple Disease-Oriented Teams (DOTs) to aid in the organization and operations of the clinical research enterprise and to provide workflow consistency to the Investigators conducting the trials. CTU CRCs assist Investigators by coordinating and executing the following clinical trial activities:
The Protocol Review & Monitoring Unit provides centralized management and oversight assistance for our review committees for cancer clinical trials. PRM coordinators manage the following administrative activities:
The Regulatory Affairs Unit provides centralized assistance for regulatory affairs for cancer clinical trials by management of the following activities: