eRegulatory Management System
eRegulatory Management System
The Office of Clinical Research is spearheading the implementation and migration to eReg.
As an Advarra product, eReg is a new Regulatory Binder Management System that integrates seamlessly with OnCore. Transitioning to this tool will minimize most duplicative efforts and inconsistencies previously experienced between the two systems. These more streamlined processes will help improve our capabilities and enhance efficiencies.
For more information, please visit Migration to Ereg.
OCR has begun training and is currently developing eReg protocols for users within each Disease Working Group at WCI. We anticipate the full implementation of WCI protocols by Summer 2025.
We are not currently accepting Medicine enrollments for the use of eReg. For more information, please reach out to the Office of Clinical Research.
Features
Advarra eRegulatory Binder will enhance your routing, workflows, and streamline processes. eReg allows shared documents and records across multiple protocols, efficiently provides secure remote access to sponsors and monitors, centralize document management, and integrates seamlessly with Advarra OnCore Clinical Trial Management System.
Contact
Need help troubleshooting a specific issue in eReg? Request one-on-one support via Zoom by emailing Clinical_Research@URMC.Rochester.edu with a description of your issue. The OCR Team will be in contact to set up a web conference time.
FAQs
OCR is holding QAs based on assignable eReg access roles.
- Users granted Read Only and Principal Investigators roles
- Users granted Regulatory Coordinator and Regulatory Manager roles
- Email the OCR Trainer, Meredith Perrin, for role-based training assignments. Confirm completion with the OCR Trainer by providing a Certification of Completion/Screenshot.
- Trainer will request your Live eReg Account creation. Users will receive a 24-hour valid confirmation link to "Confirm" activation, after which they can login to eReg with their URMC NetID and Password.
- After logging in, in the top right corner, you’ll see your username. Click the drop-down arrow, select User Profile, then click Set PIN. You’ll set your PIN once, every 90 days, before you’ll be prompted to set a new PIN. Click Forgot PIN to reset.
- Once you have set a PIN, you can sign documents. Using the Main Menu drop-down, select Sign Documents. Every single document must be viewed, reviewed, and signed as an individual document.
No, you can currently only search by the Protocol (OnCore) Number, NCT Number, or Full Title.
- Search for the Protocol Number; ClinicalTrials.gov
- You can also ‘Favorite’ your protocol(s) by selecting the Star icon next to the title, which will add the protocol to your homepage widget.
- Documents migrated from Complion will retain their current naming convention. Documents uploaded to eReg will no longer be labeled “current” or “archived”, rather we will utilize the versioning functionality.
- Documents can be uploaded at any time, and users will always see the most current document first. The version number will continue to increase, and the documents are sorted by effective date and valid until date.
Email OCR CTMS Team for support.
Email OCR CTMS Team, and the OCR Trainer, Meredith Perrin, for role-based training assignments. Following completion, the Trainer will request your Live eReg Account creation. Users will receive a 24-hour valid confirmation link to "Confirm" activation, after which they can login to eReg with their URMC NetID and password.