Clinical Trials Unit

The School of Medicine (SOM) is developing a new, full-service Clinical Trials Unit (CTU), intended to serve the School of Medicine, UVA Health, and the entire University of Virginia. The CTU will provide a centralized infrastructure to support our clinical research in a methodologically sound, compliant, efficient, and cost-effective manner.

WHY  Our goal is to assist and strengthen clinical researchers as they facilitate and execute high-quality human subject research. The CTU will aid the School of Medicine, UVA Health, and the University of Virginia to achieve our shared mission to transform research and inspire hope for all Virginians and beyond.

WHEN  Coming in Spring 2024, final date TBD.

WHO  The CTU will be managed by the SOM Clinical Trials Office, under the leadership of Linda Duska, MD, interim Senior Associate Dean for Research and Associate Dean for Clinical Research, and directed by Lori Elder, Director of the Clinical Trials Office.

WHAT  The CTU will provide the following services:

• Regulatory start-up and management support for drafting and completing the documents required for study initiation, and for maintaining the regulatory documents throughout the study.
• Clinical research coordinator pool of trained research coordinators available for “hire” on a part-time basis.
• Financial management including support for budget development, clinical trial billing and sponsor invoicing.
• Subject recruitment assistance in assessing feasibility and reaching appropriate subjects.
• Project management including management of multi-site, investigator-initiated studies.
• Clinical research coordinator training and mentoring, full service training and mentoring services for clinical research coordinators.
• Protocol writing and development assistance with developing and preparing a protocol document.
• Study start-up support in preparing for IRB submission with full service support in CR connect.
• IND/IDE submissions to the FDA oversight and assistance with applications and follow up.
• Clinicaltrials.gov support for registering the study, updating records, and importing study results.
• Research billing support such as billing coverage analysis and Epic billing assistance.
• Electronic support enhancements, improvements and updates of OnCore (Clinical Trials management system), CRConnect (study start-up), Florence (eReg), and EPIC research system.
• Clinical research unit, an outpatient clinical research space, located on grounds in the Collins Wing and another at Fontaine, available to clinical research teams for the conduct of study visits.  

Watch this page for updates to the Clinical Trials Unit progress.