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INFORMATION FOR

Advarra eReg

Advarra eRegulatory Management System

Advarra eRegulatory Management System (eReg) is an electronic regulatory binder maintenance system that allows organizations to store essential protocol documents, staff credentials, and organizational regulatory tracking documents. Advarra eReg allows users to share staff credentials and organizational regulatory tracking documents between protocols and manage effective and valid until dates on documents and URLs. Documents that require signature can be routed for electronic signature in a manner that is compliant with 21 CFR Part 11. Users receive a notification when their electronic signature is required. Study staff, monitors, auditors and inspectors access Advarra eReg via web-based interface. Review sessions can be configured, allowing Sponsors the ability to remotely monitor regulatory binders.

eReg User Access & Training

To obtain an eReg user account, please complete the online user access request form. Once the request form has been submitted, eReg Support will reach out to you via email with information to complete the required training.

System training for Advarra eReg is role-based. All users will complete system training via Advarra University. Additional content-specific training will be required for certain user roles and will be conducted by YCCI.

Note for all Internal Yale/Yale New Haven Hospital (YNHH) Users

Internal Yale and YNHH employees must have a contact record created in OnCore before an eReg account can be granted.

Additionally, new internal Yale and YNHH users will need current credential documents at the time of requesting user access. To obtain eReg access, new internal users must have all applicable and current credential documents filed in eReg.

  • Good Clinical Practice (GCP) training certificates and signature samples are required for all internal users, regardless of role.
  • Medical License and CV are required for all users identifying as a Principal Investigator or Sub-Investigator
  • Medical License is required for other credentialed users (ex. Nurse coordinator)

A Signature Sample form can be found here.

Please refer to the eReg Management System Access Guide for additional information.

eReg Protocol Import/Creation

Protocols are imported from OnCore into eReg by the Yale Center for Clinical Investigation (YCCI) eReg Support staff. The timing of protocol import depends on whether or not the department managing the regulatory binder is exclusively using eReg to maintain its regulatory files.

  • For departments exclusively using eReg to maintain their regulatory files, a protocol requiring International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) compliance is imported once the risk assessment has been completed in OnCore by YCCI.
  • For departments that are not exclusively using eReg to maintain their regulatory files, and/or for protocols that will not be in OnCore, a protocol is imported upon request via the eReg Protocol Import Request Form. The form must be completed for each protocol needing to be imported into eReg.

Users in eReg with a role of Yale Regulatory Manager who are assigned to the same department as the imported protocol will automatically have access to the protocol once it has been imported/created in eReg.

  • For Yale Cancer Center (YCC) studies, staff will not be added to the eReg protocol by the eReg Support team. YCC Regulatory Managers have access to view and edit all YCC protocols upon import.
  • For non-YCC studies in departments exclusively using eReg, staff will not be added to the eReg protocol by the eReg Support team. The Regulatory Manager(s) designated for the department have access to view and edit all protocols associated with their department upon import.
  • For non-YCC studies in departments that are not exclusively using eReg, the requestor listed on the Protocol Import Request Form will be added as staff to the imported protocol. The requestor will have access to view and edit the protocol upon import.

If your department is interested in exclusively managing and maintaining your protocols’ regulatory documents in eReg moving forward, please reach out to eReg.Support@yale.edu.

Please refer to the eReg Protocol Import/Creation Guide for additional information.

eReg Guidance Documents and Tools

21 CFR Part 11 Compliance Documents

Recent eReg System Communications

(Not all communications are sent to all users)

Support or Questions with eReg?

eReg Central Credential Filing