An event which occurs in a study under the supervision of the UM IRBMED and whose PI is a UM faculty or staff member. The event is a UM Event when it occurs at UM (including any UM hospital, health center, or other facility) or any other site where the UM PI has oversight, even when the PI is physically in another location. It does not matter where the subject experiences or is treated for the Adverse Event. If interventions take place at different UM locations (e.g., the Michigan Clinical Research Unit {MCRU}), please specify at which location the event occurred.