The Clinical Trials Support Office and OnCore CTMS Team are happy to announce the upcoming launch of Advarra’s eReg application for managing essential research documents. This new addition to our research infrastructure is a 2022 Research Priority and is made possible by the commitment of the departments and Medical School Office of Research to the Clinical Trials Transformation and conducting high-quality clinical trials. As part of the Clinical Trial Transformation, we remain committed to continuing to offer state-of-the-art tools and resources to our study teams, especially for our coordinator community.
What is eReg?
Advarra eReg replaces the regulatory binder and offers an online system to electronically manage and store essential regulatory documents typically maintained by study coordinators. In combination with other research applications, such as eRRM, the addition of eReg offers Principal Investigators and study teams the necessary tools to manage regulatory requirements remotely. This 21 CFR Part 11 compliant system integrates with the existing U-M OnCore Clinical Trials Management System, tracks document owners and expiration dates, and routes documents for signature and other notifications. Principal Investigators can also review and sign delegation of authority documents electronically.
eReg offers numerous end-user benefits such as supporting in-person and remote work, and the elimination of duplicate workflows. The system is designed to help regulatory coordinators maintain audit-ready study binders and provides study sponsor monitors secure access, resulting in improved regulatory compliance. Most importantly, eReg provides an optimized regulatory workflow that reduces the time and effort needed to gather and complete regulatory documents required to activate a study.
Training for eReg will begin in early 2022, with a go-live goal for the first quarter of the calendar year. More information on the eReg launch can be found here. Additional instructions for training are forthcoming and will be sent directly to end-users from the Clinical Trials Management System team.