Advarra eReg is a cloud-hosted vendor managed system for the management and storage of regulatory documentation related to human subjects research. The eReg system is a 21 CFR Part 11 compliant system that is complimentary to OnCore, another Advarra-developed application utilized at University of Michigan. Features of eReg include the ability to utilize shared documents across multiple protocols, remote monitoring capabilities, standard operating procedure (SOP) management, and other features that support the use of the electronic study binders. By utilizing eReg, study teams are equipped with a standardized application for storing essential research documents that are audit ready, have increased regulatory compliance, and optimized regulatory workflows that reduce time to activation per study. Users must first request and obtain access to OnCore in order to utilize eReg.
