Advarra eReg

Advarra eReg is a 21 CFR Part 11 compliant electronic regulatory management system that allows regulatory staff to organize study documents in a fully customizable online binder and quickly and easily route study documents for electronic signature.

Advarra eReg helps regulatory staff:

• Manage document versions and expiration dates
• Centrally maintain staff credentials and organization regulatory documents
• Use premade binder templates for quick study startup
• Integrate study information between OnCore CTMS and Advarra eReg
• Configure review sessions for remote external monitors
• Leverage master delegation of authority (DoA) to streamline DoA signing
• Run reports and receive alerts for document expirations, signature status, and document access
• Manage participating site documents as the coordinating center of a multi-site trial
• Includes optional subject binder and SOP repository

Advarra eReg is free for use by any UK regulatory team.

To request eReg system access, please submit our Advarra eReg User Access Request Form.

PIs and study personnel need access to the eReg system to view study binders and sign documents. Access requests should be submitted by a Regulatory Manager/Coordinator using our Advarra eReg User Access Request Form. 

External monitors need access to the eReg system to review study documents. Access requests should be submitted by a Regulatory Manager/Coordinator using our Advarra eReg User Access Request Form.

Training is required before Advarra eReg account activation and for changes in security roles. Training will be assigned based on security role and involves a combination of SOP review, web-based e-learnings, and/or live virtual training depending on requested access.

Log into Advarra eReg here using your UK Linkblue username and password. Accounts are deactivated after 180 days of inactivity. Refresher training may be required to reactivate an account.

Contact us at eReg.Support@uky.edu