- Do not wait to submit a reportable event to the IRB until you have all the information about the event. Report the event promptly and follow-up with additional information as it becomes available.
- A UPIRSO (Unanticipated Problem Involving Risks to Subjects or Others) that is also a Serious Adverse Event must be reported ASAP, but no later than one (1) week from the time you become aware of the event.
- All other UPIRSOs must be reported ASAP, but no later than two (2) weeks from the time you become aware of the event.
- Protocol violations must be reported ASAP, but no later than one (1) week from the time you identify the issue.
- Other events that are reportable to the IRB include subject complaints and breach of confidentiality.
For more information, please review UNC SOP 19.0 and 23.0
https://research.unc.edu/wp-content/uploads/2014/05/2014-04-24-OHRE-Standard-Operating-Procedures-FINAL-CLEAN.pdf