eRegulatory Management System
eRegulatory Management System
As an Advarra product, eReg is a new Regulatory Binder Management System that integrates seamlessly with OnCore. This tool will reduce most duplicative efforts and inconsistencies previously experienced between Complion and OnCore. These more streamlined processes will help improve our capabilities and enhance efficiencies.
For more information, please visit Migration to Ereg.
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The Office of Clinical Research, alongside Wilmot Cancer Institute Clinical Research Leadership, has successfully completed the implementation and migration to the eRegulatory Binder Management System; Advarra eReg as of November 4th, 2025.
Following the results of a recent survey to gauge interest, the OCR has begun planning and discussing the implementation of eReg with Non-WCI departments.
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, centralizes document management, and integrates seamlessly with Advarra OnCore Clinical Trial Management System.
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Monitor, Reviewer, and Auditor Requests
The Office of Clinical Research is requiring all Monitors, Reviewers, and Sponsors to verify their information, review, sign, and date a supplemental training document to gain access to our eReg Environment. The main point of contact for the study team can request access for a Monitor, Sponsor, or Auditor by completing the eReg Monitor Access Request form. Once the study team member requests the monitor’s access, an email will be sent to the reviewer. The Reviewer will need to complete all steps in the URMC Monitor Verification Reviewer Information form, shared in an email survey by the OCR. The monitor and the study team’s contact will receive an email confirming receipt once the monitor has submitted their completed form. The CTMS Team will then create the account and grant the monitor access to our eReg environment. This process typically takes one week. After the account is created, an email will be sent to the monitor to confirm their account. They’ll then be prompted to create a password and then directed to the eReg environment. Ensure the monitor is assigned to the correct Review Session by the study team so that they can view the appropriate binders once they are in the system.
Contact
Need help troubleshooting a specific issue in eReg? Request one-on-one support via Zoom by emailing the Office of Clinical Research with a description of your issue. The OCR Team will be in contact to set up a web conference time.
FAQs
Visit the OCR shared Box folder, containing useful role-specific resources.
- Users granted Read Only and Principal Investigators roles
- Users granted Regulatory Coordinator and Regulatory Manager roles
- Email the OCR Trainer, Meredith Perrin, for system role-based training assignments. Confirm completion with the OCR Trainer by providing a Certification of Completion/Screenshot.
- Your assigned system role can be different from your Delegated Tasks role or protocol role, i.e. you are a delegated as a Research Coordinator on a protocol, but the system reflects a Read Only role.
- 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 the blue Set PIN button. You’ll set your PIN once, every 90 days, before you’ll be prompted to set a new PIN. Click Forgot PIN to send a PIN reset email.
- Once you have set a PIN, you can sign off on your delegated tasks and any routed documents. Using the Main Menu drop-down, select Sign Documents. Any Delegated Tasks and documents routed for your signature populate. Every single task and 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 the OCR CTMS Team for support regarding internal sponsors.
The Office of Clinical Research requires all monitors, reviewers, and sponsor representatives requesting eReg access to verify their information and review, sign, and date a supplemental training document prior to account creation. This verification and training process is completed once per user.
The study team’s designated point of contact may request access for a user by completing the eReg Monitor Access Request form. After the request is submitted, the user will receive an email containing a link to the URMC Monitor Verification Reviewer Information form, which is distributed by the OCR via email survey. The user must complete all required steps in the form. Upon submission, a confirmation email will be sent to both the user and the study team point of contact.
The CTMS Team will create the account and enable role-specific access within the eReg environment. This process typically takes one week. Once the account is created, the user will receive an email confirming account setup and providing instructions to establish a password and access the eReg environment.
Study teams must assign the user to a Review Session with the correct study and review dates to enable access to the assigned binders. For subsequent review periods, a new access request is not required.
The Review Session dates act similarly to document dates. Access is granted or expires at 12:01 a.m. on the exact end date entered. This causes the document status to reflect expired even when it may not be, which also denies the reviewer access. It is best practice to add one additional day after the documented end date to the Review Session to ensure your Reviewer has access for the entirety of the session.