Occasionally, reportable events occur on studies that are not currently active or approved in ARROW, or for which an approved protocol never existed. For example:
In these cases, study teams should first contact the Health Sciences IRB Office to discuss the event and confirm that submission is necessary. Then, study teams should complete a pdf of the Reportable Event submission form, providing the same information as would be required in ARROW.
The completed form, plus any supporting documentation (e.g. Action Letters, DSMB reports, correspondence for subjects, etc.), should be emailed to the Reportable Event Point Person (Jessie Johnson) with a copy to IRBReview@medicine.wisc.edu.
Study teams will be contacted via email during the pre-review process and will be notified if any follow-up action is necessary, or, if needed, when the event is scheduled for IRB review.