How to Complete Reportable Events

How to Complete Reportable Events

Completing a reportable event in ARROW is similar to the current paper process. If you are unsure as to whether a reportable event needs to be submitted, please see the Unanticipated Problem/Adverse Event Reporting Decision Guide.

STEP 1: To create a new reportable event, click the New Reportable Event button in the main study workspace for a study in the Approved or Expired state.


This will open up the reportable event application, which allows you to choose what type of reportable event it is. The list of choices includes:

  • New Information
  • Noncompliance
  • Serious Adverse Events
  • Unanticipated Problems

Please check ANY and ALL choices you feel are applicable to the type of event you are reporting.

STEP 2: Complete the reportable event application, including a description of the event(s). Upload any relevant supplemental information within the application. Click finish when the reportable event application is complete.

STEP 3: After clicking finish in the reportable event application, ARROW will take you to a new workspace for the reportable event. Under My Activities on the left side of the workspace, you will see a Submit option. MAKE SURE to click SUBMIT as this is the final step necessary to send the reportable event to the IRB for review.

Tips for Completing Reportable Events

  • Please note: Reportable events can be submitted regardless of any other actions currently under review.
  • If the reportable event will result in a change to the study protocol, consent documents or any other study materials, please submit a change of protocol in addition to the reportable event.


Keywords:unanticipated problem, adverse event, new information, noncompliance, serious adverse event   Doc ID:17385
Owner:Stella K.Group:Health Sciences IRBs
Created:2011-03-21 19:00 CDTUpdated:2015-10-13 15:08 CDT
Sites:Health Sciences IRBs
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