eReg Binder system
Streamline Your Regulatory Process with our eReg Electronic Binder System
No more paper binders!
Save money, improve efficiency, and enhance regulatory compliance across your organization with a 21 CFR Part 11-compliant system designed to adapt to regulatory workflows for any size research site.
Please Note: Use of eReg for Investigator Initiated Trials will be required for all NEW studies holding an IND/IDE starting July 1, 2023.
eReg Orientation and Office Hours
For questions and personalized team training with eReg feel free to book a virtual appointment with our help desk! All appointments are 30 minutes. If you need more time you may book multiple appointments.
Why use ereg?
Improve routing and workflows
Quickly and easily route documents, automatically alert staff when new documents are available, and boost regulatory compliance and efficiency with electronic signatures for protocol documents, delegation of authority, and more.
Apply shared documents and records across multiple protocols
Create standard templates for protocol-essential documents tailored to each study type (NIH, industry, etc.) to use repeatedly, and share staff credentials across multiple protocols.
Easily and securely allow remote access to sponsors and monitors
Allow monitors to conduct fully remote monitoring visits and source document verification during a specified time using Advarra eReg’s remote monitoring capabilities.
Master electronic master delegation of authority process
Allow Principal Investigators to standardize delegated tasks at the system or protocol level, dramatically reducing the amount of time spent routing and obtaining signatures and documents.
Integrate with your enterprise systems
Improve productivity and compliance by integrating eReg with Advarra’s CIRBI platform, eIRB systems, OnCore, Clinical Conductor, and your internal email system.
Expand your remote capabilities, centralize document management, and move beyond paper binders
Save staff time, effort, and money when easily storing signed consent forms, contact information, compensation records, and more. Centralize your organization’s SOP document storage and management, allowing quick access for internal staff and sponsor monitors.
Efficiently and compliantly manage multi-site trials
As a coordinating center, view and manage protocol documents for participating sites in an investigator-initiated trial.
Training For eReg Access
Advarra University
Advarra University is full of helpful eLearnings for all things eReg. If you have any questions, or need to be added/activated in Advarra University, submit a Service Now ticket and let us know!
For a list of additional FREE eLearnings to assist in learning the eReg system see our Advarra University Course Catalog. You can "shop" for these free courses in Advarra University and complete the trainings at any time!
The following 8 eLearnings are required to be completed in order to have access to eReg. Once all have been completed please let us know by requesting access to eReg through a Service Now Ticket. Let us know the dates of completion for the required courses listed below and we will validate your completion dates.
- Advarra eReg 100: Navigation eLearning (8 minutes)
- Advarra eReg 101: Setting and Resetting Your PIN eLearning (8 minutes)
- Advarra eReg 102: Reviewing and Signing Documents Electronically eLearning (5 minutes)
- Advarra eReg 107: Build and Manage Protocols eLearning (35 minutes)
- Advarra eReg 108: Managing Documents eLearning (20 minutes)
- Advarra eReg 109: Creating Review Sessions eLearning (20 minutes)
- Advarra eReg 110: Using Review Sessions eLearning (15 minutes)
- Advarra eReg 111: Delegation of Authority (20 minutes)
eReg User Roles
When requesting access to eReg let us know which of the following user roles will apply to you.
Utah - Administrator
Provides the ability to manage application configurations, authentication, contact records, user roles, and organization records. This role has global access to manage the system.
Utah - Affiliate Access
Provides the ability for users at other organizations to log in, upload documents, and send copies of those documents to the coordinating center. Access is available to assigned studies only.
Utah - Monitor
Provides the ability to view any review session to which the user has been assigned as a reviewer.
Utah - Principal Investigator
Provides PI access to review and sign documents. Access is available to assigned studies only.
Utah - Regulatory Coordinator
Provides the ability to add and edit contact records, view and edit organization records, and create and view review sessions globally. This role can do a variety of tasks for protocols to which they are assigned, such as create and edit the protocol record, manage protocol staff, and view and edit protocol documents/URLs. Protocols are available at a department level.
Utah - Signer
This role provides access to the system for signatures only. Access is available to assigned studies only.
