How are the criteria defined that are used to assess whether an unanticipated problem constitutes a UPIRTSO?
Unanticipated (unexpected) problems/events are those that are not already described as potential risks in the consent form, not listed in the Investigator’s Brochure or not part of an underlying disease. Anticipated (expected) problems are those that are already described as potential risks in the consent form, listed in the Investigator’s Brochure or part of an underlying disease. These do NOT meet the IRB’s definition of UPIRTSO and should be reported in summary form only at the time of IRB continuing review. For example, if death is an expected outcome, this event should be reported only at the time of continuing review. Problems/events that are unanticipated should be reported to the IRB within 10 working days only if in the opinion of the local investigator they are possibly, probably or definitely related to the research procedures. Unanticipated problems/events that the local investigator deems unlikely or not related do NOT meet the IRB’s definition of UPIRTSO. • Follow-up repo
