Overview

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). 

• NOTE: Be sure you're entering the currently approved version of the study by checking the "Status" column for the words "Approved," "Exempt," or "External Reliance" (see red box in screenshot below).
• NOTE: For studies which rely on a non-UCSD IRB (noted by a status of "External Reliance") researchers do not need to report all reportable events submitted to the reviewing IRB. For a list of required reports, please see our sIRB page on Reliance Requests.

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. 

• NOTE: If you wish to start an event but not submit it, please be sure to click the "Save" button on the right-hand side of the screen before navigating away from the page to save your work (see green box in screenshot below). 

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).