Reportable Event Submission Instructions for Studies or Projects That Are Not Active or Approved in ARROW

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:

  • Noncompliance involving the conduct of research activities without an associated IRB application,

  • Noncompliance for a study that is still undergoing IRB pre-review, or

  • New information or noncompliance occurs on a study that is no longer active in ARROW (i.e. a study that has been archived), prohibiting any new submissions.

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.



Keywords:unanticipated problem, adverse event, new information, noncompliance, protocol exception, deviation reporting   Doc ID:18310
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-04-25 19:00 CDTUpdated:2018-10-15 12:50 CDT
Sites:Health Sciences IRBs
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