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Lee Cranmer, MD, PhD, Director
The goal of the Centralized Cancer Clinial Trials Unit (C3) is to integrate and facilitate the management, coordination and conduct of clinical research at The University of Arizona Cancer Center and to ensure that the clinical trial processes meet local, state, and federal policies and regulations. The following objectives are designed to accomplish this goal:
To provide centralized administration and processing of clinical trial documentation via the Cancer Center Clinical Trials Office (CTO).
To provide centralized Data Management and Research Nursing services.
To oversee and ensure quality control in the conduct of Cancer Center clinical trials.
To implement and maintain web-based clinical trials management system (OnCore®).
To create and manage clinical trial budget and contract.
To provide Inventory control for all investigational agents and to prepare novel formulations and combinations of agents for pilot clinical trials.
The director and the associate director of the Centralized Cancer Clinial Trials Unit (C3) oversee the clinical trials day-to-day operations. All clinical trial-related documents flow through The University of Arizona Cancer Center Clinical Trials Office for review, processing for further distribution and submission, and/or maintenance in study-specific regulatory files. The CTO also provides administrative support for the Cancer Center Scientific Review Committee (SRC).
Clinical research activities are accomplished via teams consisting of clinical investigators, research nurses, clinical research coordinators/data managers along with regulatory assistants (IRB coordinators) and other administrative support. The University of Arizona Cancer Center Data and Safety Monitoring Board (DSMB) is responsible for overseeing patient safety, study progress and data quality in Cancer Center clinical trials. The Cancer Center has implemented a web-based clinical research management system to be used as a centralized institutional database to capture clinical research protocol and subject data and generate reports concerning institutional clinical research. This system also enables us to post all of the opened clinical trials on the Cancer Center website. The C3 also assists PIs in clinical trial budget development and billing management. The University of Arizona Research Pharmacy maintains and dispenses the investigational agents and completes the investigational drug logs.