Clinical Trials Unit
The School of Medicine (SOM) has developed 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 provides 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 aids 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.
WHO The CTU is managed by the SOM Clinical Trials Office, under the leadership of Linda Duska, MD, Associate Dean for Clinical Research, and directed by Lori Elder, Director of the Clinical Trials Office.
WHAT The CTU provides the following services:
- Regulatory start-up and management support streamlines the process of organizing, maintaining, and submitting regulatory documents to the IRB of record. Our team will liaise with sponsor contacts and initiate and manage the eRegulatory binder (Florence).
- Clinical Research Coordinator (CRC) pool of trained research coordinators available for “hire” on a per diem basis.
- Financial management support including budget development, billing coverage analysis (BCA) development, Epic research billing assistance, and sponsor invoicing.
- Subject recruitment assistance in assessing feasibility and reaching appropriate subjects.
- Multicenter Project Management of investigator-initiated studies for which a UVA Investigator serves as the lead PI.
- Clinical Research Mentoring and Education, provides support, training and educational offerings to clinical research coordinators across UVA.For more information visit our intranet page.
- Protocol writing and development assisting the investigator and the study team to draft a submission ready protocol document. Guidance is provided on areas of study design such as inclusion and exclusion criteria, primary outcomes and endpoints, and creating a comprehensive Schedule of Activities for your trial.
- IND/IDE submissions to the FDA Consultations are available to determine if your trial requires FDA oversight. We provide IND/IDE application drafts and will submit to the FDA on your behalf. Our office provides guidance on the regulatory landscape of becoming an IND/IDE holder.
- OnCore, CRConnect, eREG The University of Virginia has several systems to help you conduct research: CRConnect, OnCore and Florence eRegulatory, as well as a team for each system to help support you in your efforts.
- Clinicaltrials.gov at UVA available to assist teams with the mandatory trial registration process, record maintenance and results entry.
- 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.