Get started with eReg in virtual eReg training!

Everyone must attend eReg training and pass the eReg training certification program to gain access

The eReg module is a part 11 compliant, online regulatory binder available to all faculty. Training is required and role-based, even for PIs.

Because it is separate from OnCore and not part of the OnCore budget, eReg comes with a cost. Any industry-initiated and funded clinical trial that wants to use the eReg module must pay a $1,000 fee good for the life of the study. (Investigator-initiated trials and federally funded studies do not have to pay for use of eReg.)

Why use eReg? Advantages include remote monitoring of the regulatory documents by a sponsor for one; they even have their own role (requires separate access request and separate training). Note: While CHCO leadership is reviewing the system, CHCO study teams are not permitted to utilize the eReg system.

How to Gain Access to eReg

1

Fill out the eReg access request form

eReg Access Request Form

2

Provide information

The eReg Access Request Form will populate required courses at the end of the form, so be sure to note your required training before you click submit!

3

Complete your training

Receive an email with your assigned training course(s) and instructions for accessing the training. Complete your training and pass your evaluation

4

Access granted to eReg

Accrual and IRB status must be kept up-to-date in OnCore.

Need access changes?

Please submit changes to the eReg Access Request Form.

Request eReg for your study

Please fill out the eReg Study Access Form.

Questions?

Please email Clinical Research Support with any questions.

Training Courses

Module	Description
Advarra eReg 113: Managing User Roles and Permissions eLearning	Describes an overview of the available standard roles, how to create or copy a role, and the different permissions.
Advarra eReg 100: Navigation eLearning	Describes the functionality, ease, and use of Advarra eReg.
Advarra eReg 101: Setting & Resetting Your PIN eLearning	Describes how end users can set/reset a PIN in order to electronically sign off on documents.
Advarra eReg 102: Reviewing and Signing Documents Electronically eLearning	Describes the process for reviewing documents and executing signature requirements.
Advarra eReg 103: Managing Contact Records eLearning	Describes how to import, create, and edit a Contact Record. It also describes how to manage digest notifications and copy contact information.
Advarra eReg 104: Maintaining Reference Lists eLearning	Reference lists are used throughout eReg to drive the choices that users see when they are filling out the information in the system. For example, the Section Name reference list contains the names of all of the sections users can choose from when creating a regulatory template or a protocol outline, while the Lab Regulatory Item Type reference list includes all of the options that users can choose from when adding regulatory tracking items to organizations that are defined as laboratories.
Advarra eReg 105: Managing Organization Records eLearning	Describe how to create, import, and edit an organization record. It also describes how to associate contacts with an organization.
Advarra eReg 106: Managing Regulatory Templates eLearning	Describes how to create a template, add information about staff and organizations, add additional sections and requirements, rearrange sections, update a template status, and use Save As to create a new template.
Advarra eReg 107: Protocol Management eLearning	Describes creating a protocol, understanding protocol views, editing a protocol's structure, understanding document/URL statuses, adding documents/URLs to a protocol, understanding signature requirements, adding new versions of documents/URLs, and configuring signature messages.
Advarra eReg 108: Managing Documents eLearning	Describes how to manage and add documents/URLs to eReg at the contact credential, protocol, and organization level.
Advarra eReg 109: Creating Review Sessions eLearning	Describes how to set up protocol review sessions for external monitors and auditors.
Advarra eReg 110: Using Review Sessions eLearning	Describes how to access a review session and review documents.
Advarra eReg 111: Delegation of Authority eLearning	Describes the process of managing assigned tasks for users as well as how the PI reviews and signs off on the documentation.
Advarra eReg 112: Reports eLearning	Describes report functionality within Advarra eReg, including how to run standard reports, parameters available, selecting output type (XLSX, CSV, etc.), and queued tasks.
Advarra eReg 201: Integration with OnCore eLearning	Describes the OnCore to eReg integration via Hub. This includes importing organizations, protocols, protocol staff, contacts, protocol staff role reference list, and how to research integration discrepancies.
Advarra eReg 301: Multi-Site Terminology eLearning	Defines terminology used when managing multi-site protocols within eReg.
Advarra eReg 302: A Look Into Multi-Site Workflows eLearning	Describes the overall multi-site workflow. Highlights the functionality to help Coordinating Center Administrators, Coordinating Center Staff, Research Center Study Site Staff, Participating Site Staff, Non-Data Exchange Affiliate, and Participating Site Staff, Data Exchange Affiliate manage their multi-site protocols.

Module	Description
Advarra eReg 100: Navigation eLearning	Describes the functionality, ease of use of Advarra eReg.
Advarra eReg 101: Setting & Resetting Your PIN eLearning	Describes how end users can set/reset a PIN in order to electronically sign off on documents.
Advarra eReg 102: Reviewing and Signing Documents Electronically eLearning	Describes the process for reviewing documents and executing signature requirements.
Addvarra eReg 111: Delegation of Authority eLearning	Describes the process of managing assigned tasks for users as well as how the PI reviews and signs off on the documentation.
Advarra eReg 112: Reports eLearning	Describes report functionality within Advarra eReg, including how to run standard reports, parameters available, selecting output type (XLSX, CSV, etc.), and queued tasks.

Module	Description
Advarra eReg 100: Navigation eLearning	Describes the functionality, ease of use of Advarra eReg.
Advarra eReg 110: Using Review Sessions eLearning	Describes how to access a review session and review documents.

Module	Description
Advarra eReg 100: Navigation eLearning	Describes the functionality, ease and use of Advarra eReg.
Advarra eReg 101: Setting & Resetting Your PIN eLearning	Describes how end users can set/reset a PIN in order to electronically sign off on documents.
Advarra eReg 102: Reviewing and Signing Documents Electronically eLearning	Describes the process for reviewing documents and executing signature requirements.

Tools & Resources

Schools & Colleges

CU Denver

CU Anschutz Medical Campus

CU Campuses

Clinical Research Administration

Regulatory Compliance

Get started with eReg in virtual eReg training!

How to Gain Access to eReg

Fill out the eReg access request form

Provide information

Complete your training

Access granted to eReg

Training Courses

Get started with eReg in virtual eReg training!

How to Gain Access to eReg

Fill out the eReg access request form

Provide information

Complete your training

Access granted to eReg

Training Courses

Advarra eReg 1100: Regulatory Manager Course eReg Modules

Advarra eReg 1200: Principal Investigator Course eReg Modules

Advarra eReg 1300: Reviewer (Internal & External Monitor) Course eReg Modules

Advarra eReg 1500: Document Signer (Study Teams) Course eReg Modules