Reportable Events: Process

This page describes the ED/SBS IRB Reportable Event process.

Pre-Submission
Reportable Event applications should be submitted as soon as the study team becomes aware of the event and at least within 14 business days, per campus policy.  If additional time beyond this deadline is needed to investigate and identify causes, study teams must still adhere to the deadline and inform the IRB that investigation is ongoing.

See IRB Guidance: Reportable Events

Once an ED/SBS IRB Reportable Event application has been filled out by the study team, the following steps should be performed:
  • Ensure the Reportable Event Form is complete
  • Select Hide/Show Errors at the top of the application to identify any omissions;
  • Select Finish on the Final Page or Save & Exit on any page to return to the Reportable Event workspace;
  • Use the Record Human Subjects Training Snapshot activity, to ensure all study team members have the required training;
  • To submit the application to the ED/SBS IRB, the PI must review and click the Submit activity in the Reportable Event application workspace.
When an application is successfully submitted, an entry will be logged on the History tab noting the date and time of submission, and the Current State moves from Pre-Submission to IRB Administrative Review. It will then be assigned to a Staff Reviewer and move into IRB Pre-Review state.

IRB Pre-Review
An ED/SBS IRB Staff Reviewer will be assigned to pre-review an ED/SBS Reportable Event application to assess the application and supporting documents to determine the level of review required. 

See ARROW FAQ: Questions During Review to identify the assigned Staff Reviewer

If the Staff Reviewer finds information missing, or needs clarification to be able to review the Reportable Event, the application will be returned to the study team to address.

See ARROW FAQ: Responding to Issues

When the Staff Reviewer finds that sufficient information has been provided and any necessary steps have been completed by the study team, the Reportable Event application will be processed according to ED/SBS standard operating procedures. 

See Reportable Events: Review Types & Timing




Keywords:unanticipated problem, noncompliance, new information   Doc ID:67958
Owner:Stephanie W.Group:Education and Social/Behavioral Science IRB
Created:2016-10-21 15:15 CDTUpdated:2019-01-17 17:17 CDT
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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