1. 24 hour notice – When sponsor is told by PI- Death – Regardless of relatedness or expectedness
2.15 day notice- When sponsor is told by PI- Adverse Events that are either unanticipated or serious and related or possibly related
3.Within 5 days of receipt - PI or Sponsor- Safety Reports (any adverse experience associated with use of the drug that is both serious and unexpected, Any finding from tests in laboratory animals that suggests a
significant risk for human subjects including reports of mutagenicity.
4.Periodic - PI- All other events must be tabulated for submission at the time of continuing review or final report.
