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eRegulatory Management System

Streamline Your Regulatory Process with eReg

Think beyond the binder. 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.

Improve your 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.

Manage a complete 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.

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, let us know! CRSO@hsc.utah.edu

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!

Advarra University Link

The following 7 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)

eReg User Roles

When requesting access to eReg let us know which of the following user roles will apply to you.

Affiliate Access

Intended for users from outside of the coordinating center organization to give them permission to log in, upload documents, and send copies of those documents to the coordinating center.

Multi-Site Access

Import multi-site protocols, manage multi-site protocols, including organizations and staff, and manage participating sites.

Principal Investigator

  • View contact records, including credentials and delegated tasks by staff role.
  • View organization records and regulatory tracking documents in the system.
  • View and edit protocols to which they are assigned.
  • Manage staff on protocols to which they are assigned, including importing staff.
  • View credentials for staff throughout the system.
  • View and edit documents/URLs on the protocols to which they are assigned.
  • View protocol organizations on the protocols to which they are assigned.
  • Run reports.
  • View the Sign Documents page and electronically sign documents.
  • Manage protocol staff roles and their delegated tasks on protocols to which they are assigned.

Regulatory Manager

  • View application-wide settings.
  • Configure signature messages.
  • Manage staff roles and their associated default tasks at the system level and contact level.
  • Manage contact records, including managing contact credentials, resending user activation emails (when either the eReg application or the SAML authentication realm is used), initiating user account password reset (when the eReg application authentication realm is used),and maintain department information for contacts.
  • Reset the SAML association for users (when the SAML authentication realm is used).
  • Manage user roles.
  • Import data.
  • Manage organization records at the global and protocol level, including regulatory tracking items
  • Remove organizations from a protocol.
  • Manage protocols, including the ability to view and edit outlines for protocols as well as locking and unlocking protocols.
  • Import protocols.
  • Manage protocol staff and manage credentials for all staff on a protocol, including routing credentials for electronic signature.
  • Import protocol staff.
  • Edit the Inbox Configuration for all protocols.
  • View, add, and edit protocol documents/URLs.
  • Create and edit regulatory templates.
  • Update reference lists.
  • Run reports.
  • View the Sign Documents page and electronically sign documents.
  • Manage review sessions globally.

Regulatory Coordinator

  • Manage staff roles and their associated default tasks at the system level.
  • Add and edit contact records, including managing contact credentials.
  • View and edit organization records, including their regulatory tracking documents.
  • View, add, and edit organization details at the protocol level on protocols to which they are assigned.
  • View and edit regulatory tracking documents for organizations on protocols to which they are assigned.
  • Remove organizations from a protocol on protocols to which they are assigned.
  • Create protocols and edit protocols to which they are assigned.
  • View the Inbox Configuration for protocols to which they are assigned.
  • Import protocols and add protocol staff to the imported protocol.
  • View and edit the outline for a protocol for protocols to which they are assigned.
  • Manage staff on protocols to which they are assigned, including importing staff.
  • Manage staff roles and their delegated tasks for protocols to which they are assigned.
  • Manage contact credentials, including routing them for electronic signature.
  • View and edit protocol documents/URLs for protocols to which they are assigned.
  • Lock protocols.
  • View regulatory templates.
  • View user roles.
  • View the Sign Documents page and electronically sign documents.
  • Run reports.
  • Create, edit, and view review sessions globally and delete review sessions to which they are assigned.

Signer

Review and sign documents.

Subject Access

View assigned protocols and view, add, edit, and delete subject documents for those protocols.

This role is intended to be an additional role stacked on top of other roles for a user.

eReg Office Hours

For questions and additional help with eReg feel free to book a virtual appointment with our help desk! All appointments are 30 minutes and bookable 15 days in advance. If you need more time you may book multiple appointments. Once you complete your booking the appointment will generate on your calendar with a Teams Meeting link.

 

In order to sign up for training / office hours you must be logged into the University Microsoft 365 system.

To log in go to https://o365cloud.utah.edu/ with your university credentials. Once you have logged in the booking links will work on this site.

eReg Training & Support

Contact Us

Zachary Bartholomew

Sr Regulatory Coordinator