What if the Investigator determines the problem/event does not meet the criteria for UPIRTSO?
When the 3 criteria are not met, the problem/event is called a non-UPIRTSO. All problems/events that do not meet Mayo Clinic IRB’s definition of UPIRTSO should be reported to the IRB in summary format at the time of continuing review. Accompanying documentation (sponsor report form, etc) should not be included with this summary and if received will be returned to the Investigator.
