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