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 documents.  

eReg provides a centralized location for all staff credentials and organizational regulatory tracking documents. This centralized data can be utilized across multiple protocols. eReg can also manage effective dates and ‘valid until’ dates on documents and URLs. Documents that require signature can be routed within eReg for electronic signature (in a manner that is compliant with 21 CFR Part 11). A user will receive a notification from eReg when their electronic signature is required on a document  

Study staff, monitors, and auditors can access Advarra eReg via a web-based interface. Review sessions can be configured, allowing Sponsors the ability to remotely monitor regulatory binders.

 

Access and Training Steps:

UIOWA staff request training and access to eReg: eReg Training and Access request

Request eReg access for External Monitors: External Monitor eReg Access Request

Upon completion of the access request form, you will be assigned eReg specific coursework on Advarra University, which is required to be completed prior to granting your user access to eReg. 

The ICTMS administrative team will set up your coursework sessions in Advarra University and you will email the step-by-step instructions about how to complete the required coursework.  

ICTMS eReg Support: ictms-admin@uiowa.edu