Who makes the assessment of whether an unanticipated problem/event constitutes a UPIRTSO?
The IRB relies on the Mayo Clinic Investigator to provide an assessment of whether UPIRTSO criteria are met for a given problem/event. As the person most familiar with and ultimately responsible for the conduct of the study, the Investigator is the person to provide his/her assessment of whether a problem/event meets UPIRTSO criteria. The Investigator’s assessment of the problem/event should include a determination related to any changes to the approved study that should be made as a result of the UPIRTSO report.
