Resources for Sponsor Visits

Updated July 13, 2023

Onsite sponsor/monitor visits are permitted in clinical and non-clinical areas. There continues to be no limit on the number of representatives that can visit, however, we encourage you to limit the visitors to the minimum number required. Sponsor visitors are required to adhere to all mask requirements.

An electronic regulatory system that is used for clinical research studies conducted within the UVA School of Medicine.  Florence eBinders is designed to replace physical binders and paper forms, giving clinical research teams an efficient and compliant way to electronically sign, manage, store, and collaborate on study documents.  Features include:

• Remote data access – Access study binders and files from anywhere in a secure, user-friendly way.
• Electronic signatures – Study teams no longer need to physically transport paper documents from person to person or utilize DocuSign.  Signatures in eBinders are 21 CFR Part 11 compliant.
• Remote monitoring – Monitors are given access to the files they need, signed subject consents, protocol consents, and most importantly – documents which contain PHI.
• Streamlined document updating – Upload documents once and file them in multiple study binders.
• OnCore integration – The OnCore team will facilitate the creation of a “shell” protocol to sync with eBinders, making it easier to begin uploading protocol regulatory documentation at protocol start-up

For support:  Florencesupport@uvahealth.org or 434.297.5757 option 3

https://www.medicalcenter.virginia.edu/intranet/cto/florence-ebinders

There are five options for sharing information with study sponsors.  All five have been approved for use with patient (subject) related activities. You are not required to redact the information you share using these tools.