A "Safety Event" is a general term given to a study event which is related to subject safety. These currently include adverse events (reportable and non-reportable), protocol deviations and violations, and safety correspondence letters, such as DSMB communications.
User Guides are available on the eIRB website (https://eirb.mc.duke.edu) and additional information is available on the Institutional Review Board (IRB) website (http://irb.duhs.duke.edu/).