For trials that involve human beings there is a need to report any adverse events (death, prolonged hospitalization, unexpected illness) within a scheduled period by the Principal Investigator to the IRBs (usually within 48 hours). The event should be qualified as either related, probably/possibly related or unrelated to the trial. The report should be on standard reporting forms, or a format agreed upon by the IRBs and the investigators. The IRBs’ reaction to these reports may affect trial implementation.