Office of Clinical Trials Research

Research Subject Registration Requirements at the University of Vermont Health Network

The Principal Investigator (PI) or delegated key personnel of the research team are responsible for establishing and following procedures for research subject registration. The process of research subject registration must comply with federal and state regulation, University of Vermont (UVM) Health Network policy, and Good Clinical Practices (GCP) in research. Proper registration of patients as research subjects is necessary to support safe clinical care and accurate billing of research related services.

This policy applies to all research subjects at UVM Health Network sites that use EPIC. 

This policy does not apply to patients where their study participation only involves online/phone surveys, or in-person interviews/questionnaires.

The reasons we register patients as research subjects in EPIC are:

1. Patient safety is enhanced because we will be able to identify in EPIC when our patients are enrolled in clinical studies. Having a complete picture of a patient's activities across our institutions enables us to provide the safest, most appropriate care.

2. We enhance our ability to leverage EPIC as a source of information for research endeavors.

3. Centers for Medicare and Medicaid Services require that some (but not all) clinical trials claims have an accompanying National Clinical Trial Registry number.  All research claims must be identified as research – not clinical care.  Billing for research related expenses in any other way is considered fraudulent.  Significant fines have been levied against other major Academic Medical Centers for billing research related charges incorrectly.  Some institutions have been banned from doing future research due to their non-compliance of this federal requirement. Registering our patients as research subjects in EPIC enhances our ability to be in compliance with research billing regulations.

We appreciate your support of this important initiative, and look forward to the opportunities it will provide to improve research activities at the UVM Health Network and the University of Vermont.  The IRB works closely with the IT Research Subcommittee to ensure that all appropriate protections of human research subjects are in place as we better utilize EPIC to support research.

For Research Subject Registration FAQs, Research Subject Registration SOP and EPIC Tip Sheets, please visit the OCTR Commons site.