Kuali IRB Quick Sheet - Steps to Submitting a Reportable Event


During the course of the conduct of a study, events may occur which require prompt reporting to the IRB. These might arise from non-compliance with the protocol, IRB determinations, or the regulations governing human subjects research, changes that need to be made to protect a subject from imminent harm, or the discovery of new risk information. When an event that requires prompt reporting to the IRB occurs, this must be submitted as a reportable event in Kuali IRB. This KBA walks users through how to submit a reportable event in Kuali IRB. 

Steps to Take 

1. Log in to Kuali IRB

2. Find the study you wish to submit a reportable event for and enter the study record by clicking on the blue study title (see green box in screenshot below). 

3. Once in the study, click "Reportable Events" just under the blue banner across the top of the screen (see purple box in screenshot below). 

4. To report a new event, click the "Report an Event" button on the right-hand side of the screen (see orange box in screenshot below). 

5. The system will automatically generate a new reportable event application for the study. 

6. Proceed through the application answering the questions which populate. Like other Kuali applications, this application is dynamic and additional questions will populate as questions are answered. 

7. Supporting documentation about the event (e.g. monitor reports, sponsor letters, complaints, etc.) can be included in the "Addl. Info/Supporting Documents" section at the end of the application (see orange box in screenshot below). 

8. Once the application is complete and ready for submission, click the "Submit for Review" button on the right-hand side of the screen to submit the event to the IRB for review (see purple box in screenshot below).