Advarra eReg

The University of Calgary has implemented the Advarra eReg system!

Advarra eReg is a validated, regulatory compliant system for the management and storage of clinical trial regulatory documents. The system’s core functionality includes:

  • eSignatures
  • Contact-level credentials that automatically route to all of their studies (example: GCP Refresher)
  • Organization-level documents that are centrally accessible (example: Lab SOPs) 
  • Document version control 
  • Notifications of expiring documents and credentials 

Some of the benefits of using eReg include: 

  • Reduced effort to sign and file documents 
  • Remote access for study monitors 
  • Improved regulatory compliance 
  • Reduced printing and physical storage requirements 
eREg by Advarra logo, green sphere with blue lines along the bottom exterior of the sphere and blue green gradient lines on top of the sphere

We have a limited number of licenses available and are offering these on a first-come, first-served basis.

FAQs

No. The University of Calgary has already purchased a limited number of licenses.  

If we exceed our licenses, we may need to consider implementing a charge. However, we will engage with users if that ever needs to happen.

No. You may continue to use your existing GCP-compliant paper or digital document storage solutions.  

Studies and teams with office space in HMRC are required to use eReg on a go-forward basis for all studies that open to accrual after September 1, 2026. This is to decrease the amount of physical storage space required.

If you’re starting a new study and need to maintain GCP- compliant documentation, eReg might be a great solution for you. 

Factors for consideration are how much of your source documentation is generated electronically, how many signatures you’re collecting, and how many staff credentials you need to track. The higher these volumes, the more benefits to using eReg. 

Note that sponsors may provide portals for you to upload regulatory documents, but you are still required to maintain and archive your own copies.

Ideally. Everyone who needs to eSign a document will need an eReg user account. However, it is possible for you to upload already signed documents and maintain credentials on behalf of others.

HMRC and the Research Pharmacy are storing all of their regulatory documents (example: SOPs) and their staff credentials (example: GCP) in eReg. To access these documents, you will need a basic eReg user account. 

Regulatory Coordinators with a protocol in eReg can include HMRC and Research Pharmacy staff to their Protocol Staff tab. This allows you to add them to the study delegation log, automatically track their credentials, and route documents to them for eSignature.

Regulatory Coordinators (users who manage regulatory documents on a protocol) are required to watch a 15-minute, pre-recorded orientation video and document this training on a training log. Users with any other role(s) do not need to complete any training.

Yes. eReg protocols are created with a template structure for your regulatory documents and can make it easy for you to know what and where to file things. 

Running a multi-site study? 

You can use eReg as both the Trial Master File and provide eReg to your subsites for them to manage their own site documents. Note that each site using eReg will count as a license.

If you have more than a few sites needing eReg, please contact POST to make sure we can meet your needs and discuss the potential for purchasing more licenses.