Clinical Trial Unit
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About Us
The Clinical Trial Unit (CTU) is a central research unit that provides services to investigators, sponsors, and research staff conducting clinical research trials.
Services
- NDA and Feasibility Questionnaire management
- Formal Feasibility and Planning for clinical research projects
- Full-service Outpatient Research Clinic
- Coverage Analysis and Budgeting
- Obtention of facility and IRB approvals for research
- Fiscal management of research accounts
- Consent writing and review
- Development of the Investigative Site File and essential regulatory documentation
- Audit support and Standard Operating Procedures
- Corrective and Preventative Action Plan development and implementation
- Coordination of all sponsor interactions and visits
- Engaging research participants and conducting informed consent
- Obtaining all research data and creation of source documentation
- Electronic data capture
- Handling of investigative materials
- Obtention of specimens and routing for analysis as well as lab prep
- Conduction of study visits and research procedures
Equipment & Instruments
- InBody Body Composition Analysis
- -80 and -20 freezer
- Refrigerated centrifuge
Serving
- UofL Researchers
- External-Academic
- External-Industry
Core Acknowledgement
Researchers are strongly encouraged to acknowledge the use of this core facility in publications and presentations. Doing so documents the role of shared infrastructure in advancing UofL research and supports the core’s continued operation and growth.
Consider using the suggested language below when making acknowledgements in your work:
This [publication, project, or research] was made possible, in part, by the Clinical Trials Unit at the University of Louisville.
Core Personnel
Craig McClain
Professor of Medicine and Pharmacology & Toxicology
Rachel Sheppard
Senior Director, Clinical Trials Unit