The Clinical Trials Support Office is pleased to announce that Wave 1 of the Advarra eReg implementation is now underway, welcoming new studies to use eReg as their electronic study binder.
In combination with other research applications, such as eRRM, the addition of eReg offers Principal Investigators and study teams the necessary tools to manage regulatory requirements electronically and remotely. A 21 CFR Part 11 compliant application, fully integrated with OnCore, eReg will allow study teams to:
- Store essential regulatory documents
- Manage and route documents to PI's and study staff for 21 CFR Part 11 compliant electronic signature
- Manage delegation of authority for the protocol
- Provide secure access to study sponsors and monitors
Invitations have already been sent to Lead Coordinators and Principal Investigators of new studies with OnCore PRMC Approval Status dates between January 1 and February 28, 2022. Existing studies, including those with approval dates prior to January 1, 2022, will begin to utilize eReg in April during Wave 2.
In the meantime, we encourage all study team members to review the following list of resources now available:
- CTSO Work Guides SharePoint Site for information specific to eReg workflows:
For questions about eReg, please submit a ticket to the eReg Support Team.