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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.

Note: Save Signature Sample Form to Desktop Before Opening

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

eReg Protocol Import/Creation

All protocols requiring International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) compliance will automatically be imported from OnCore into eReg by the eReg Support staff for those departments who are currently using eReg. Protocols are imported from OnCore to eReg after the record is created in OnCore.

A member of the study team will be added to the staff section of the eReg binder. This staff member will have access to the protocol once it has been imported and will be responsible for adding all additional study team members to the staff list.

Users in eReg with a role of Yale Regulatory Manager, who are assigned to the same department as the imported protocol, will also have access to the protocol once it has been imported into eReg and a study team member has entered the department in the Protocol Details section of the eReg binder.

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

21 CFR Part 11 Compliance Documents