How soon must a UPIRTSO report be provided to the IRB?
A researcher should promptly assess unanticipated problems that occur on the study. Once a researcher has determined that an event constitutes a UPIRTSO, it should be reported to the IRB within 10 working days using the UPIRTSO form found on the IRB’s Web site at http://www.research.umn.edu/irb/forms.html. A UPIRTSO must be reported within this time frame, even if the event itself is not yet resolved.
