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
eReg Guidance Documents and Tools
- Delegation of Authority
- Electronic Signatures
- eReg Management System Assessment
- Investigator Site File Regulatory Templates
- Review Sessions
- Sending Copies from Investigator Site File to Trial Master File
Save Signature Sample Form to Desktop Before Opening
- Staff Training Protocol Section
- YCCI Training Slides - ISF
- YCCI Training Slides - TMF
Frequently Asked Questions
- COMING SOON Trial Master File Regulatory Templates
21 CFR Part 11 Compliance Documents
Recent eReg System Communications
(Not all communications are sent to all users)
- Yale eReg System Upgrade Notification 2022R2 - 26SEP2022
- Yale eReg Notice Regarding YCCI Central Management of Contact Credentials – 21JUN2022
Yale eReg Notice Regarding System Issue with Placed Electronic Signatures – 24MAY2022
- Yale eReg System Upgrade Notification – 09MAY2022
- Yale eReg Notice Regarding Standard Operating Procedures (SOPs) – 22MAR2022
- Yale eReg Notice Regarding Social Behavioral Templates – 03MAR2022
- Yale eREG Notice Regarding System Upgrade to 2021R3 - 11JAN2022
- Yale eReg Notice Regarding Contact Credentials and Action Required by 22-Nov-2021 – 11NOV2021
- Yale eREG Notice Regarding Delegated Task Changes- 26OCT2021
- Yale eREG Notice Regarding Department Assignments- 18OCT2021
- Yale eREG Notice Regarding User Role Changes- 18OCT2021
- Yale eREG Notice Regarding Reference List Changes (CORRECTION)- 23SEPT2021
- Yale eREG Notice Regarding Reference List Changes- 2SEPT2021