Reportable Events: Application

This page describes the ED/SBS IRB Reportable Event application in ARROW.

The Reportable Event application should provide a concise explanation of the event, including: relevant dates, how the person reporting obtained the information, and any corrective action being proposed by the Study Team.

Event Type
On the first page of the application, select the type of event being reported.

See the campus Noncompliance policy and Deviations (minor deviations that do not require reporting to the IRB)
See the campus Unanticipated Problems policy

Complete the Reportable Event Application
As part of the review process for Noncompliance and Unanticipated Problems, the IRB will review proposed corrective actions to prevent the event from occurring again.  Explain if a Change of Protocol will be required in order to update consent documents, instruments, or other parts of the ARROW file.