eRegulatory Management System

1. 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.
2. 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.

1. 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.
2. 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 is requiring all external Monitors, Reviewers, and Sponsors to review, sign, and date a supplemental training document to gain access to our eReg Environment. Study teams can request their monitor/reviewer/sponsor’s access by emailing the OCR Trainer with the request for access, including the first and last name and email address of the external user who needs access. The Trainer will process the signature request. Once the document has been signed and returned, the process to create their account is the same as for an internal user. The Trainer will request their Live eReg Account creation, and users will receive a 24-hour valid confirmation link to "Confirm" activation, after which they can log in to eReg with their assigned credentials. The Trainer will request the Monitor’s signature via Adobe Sign. Once the document has been signed and returned, the Trainer will confirm with the entire study team, as included in the initial request. The Trainer will request the Monitor’s Live eReg Account creation with the CTMS Team, after which users will receive a 24-hour valid confirmation link, with a "Confirm" activation link. Monitors can log in to eReg using their assigned credentials following the confirmation.

If any access or login troubleshooting is needed, including resending an activation email or resending a signature request, please contact both the OCR Trainer and the CTMS Team.

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.