Reportable Event
Investigators are responsible for promptly reporting any reportable event to the IRB. 45 CFR 45.108(4).
Timing: Investigators must submit a reportable event as soon as possible.
How do I start a reportable event submission?
Login into iRIS.
On the study assistant dashboard, select Forms on a study in Approved Status.
Select “IRB Reportable Event Form” to open the online reportable event submission form.
