Clinical Trials Support Unit
Director: Karen Kelly, M.D.
The conduct of high quality clinical trials is essential to the overall mission of the Cancer Center. The Clinical Trials Support Unit (CTSU) is a core facility for coordination and supervision of clinical research activities which provides centralized protocol development and implementation services, data management, reporting, and administrative oversight. The CTSU standardizes education and training for clinical research coordinators (CRCs), research nurses, and individual investigators in relation to the clinical research process. The CTSU also provides quality assurance functions, including data and safety monitoring, to comply with local institutional review board (IRB) policy and federal regulations.
Specific objectives of this shared resource are to:
- facilitate activation and conduct of cancer clinical research studies
- promote awareness and availability of active studies to Cancer Center investigators and staff
- screen candidates and facilitate enrollment of eligible patients onto clinical trials
- provide education and training for all members of the clinical research team
- promote quality assurance, research compliance, and adherence to Good Clinical Practices (GCP)