What kinds of events constitute UPIRTSOs?
The following events meet the IRB’s definition of UPIRTSO and should be reported within the 10 day time frame: • 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 possibly related to the research procedures • Any accidental or unintentional change to the IRB-approved protocol that increases risk or has the potential to recur • Any deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research subject • Any publication in the literature, safety monitoring report (including Data and Safety Monitoring Reports), interim result or other finding that indicates an unexpected change to the risk/benefit ratio of the research • Any breach in confidentiality that may involve risk to the subject or others • Any complaint of a subject that cannot be resolved by the re
