Individual Event Reporting
An individual event needs to be reported to the IRB ONLY if ALL of the following are true:
- It is unexpected
- It is related to the research
- It involves increased risk to subjects or others
If an individual event meets these criteria, it must be reported to the IRB using a Reportable New Information form in CLARA, either immediately (if it results in death or is life-threatening) or within 10 days of the event.
Summary Event Reporting
Events that do not meet the criteria for individual reporting outlined above should be reported in summary at continuing review.
Some sponsors may ask that all safety reports be submitted to the IRB immediately, even if they do not meet the criteria for individual reporting. The Memo re IND safety reporting can be shown to study sponsors to advise them of the UAMS IRB’s reporting expectations.