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.

Clipping of iRIS IRB Reportable Event Form Window 

Click to learn more about submitting a reportable event