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  • What kinds of events constitute UPIRTSOs?The following events meet the IRB's definition of UPIRTSO and should be reported within 10 calendar days of the event.Any event (including on-site and off-site adverse events, injuries, side effects, deaths or other problems) which in the opinion of the local investigator was unanticipated, involved new or increased risk to subjects or others, and was possi
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