Author: Meredith M. Hoog

Saint Louis University Institutional Review Board
Serious Adverse Event (SAE) Decision Tree

Is the event related or possibly related to participation in the research?

No

Event is not reportable to SLU IRB.

Yes

Did the event occur at SLU or a SLU affiliated site?

Yes

No

Event is not reportable to SLU as an SAE, but may still be an Unanticipated Problem (UP). Please see UP Decision Tree.

Is the event life threatening or did it result in death?

Yes

Event is an SAE.
Report to IRB within 3 days.

No

Did the event result in any of the following?
Congenital anomaly or birth defect
Significant disability or incapacity
Inpatient hospitalization or the prolonging of existing hospitalization
Any other important medical event that may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above

No

Yes

Event is not an SAE, but may still be an
Unanticipated Problem (UP).
Please see UP Decision Tree

Event is an SAE.
Report to IRB within 7 days.

SAEs are to be reported on the SAE Form in eIRB.
Studies not in eIRB can use the paper SAE Form.

Version Date: 4/2017