Overview

Once a study is completed and no further identifiable data analysis is required and there are no more interventions or interactions with subjects, the study should be closed with the IRB. This KBA walks users through how to submit a study closure in Kuali IRB. 

Steps to Take 

Studies that are still in an approved status

1. Start by logging in to Kuali IRB.

2. Find the study you wish to submit a closure 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). If the study status is "Expired," proceed to step 8 of this document. 

3. Once in the study, click "Request Close" from the right-hand menu (see purple box in screenshot below).

4. The system will automatically generate the closure application. 

5. 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. 

6. Any documents to be submitted along with the closure (e.g. final DSMB report, final auditing report, etc.) can be included in the "Closeout Attachments" section of the application (see orange box in screenshot below). 

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

Studies that are in an expired status

8. Start by logging in to Kuali IRB.

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

• NOTE: These instructions are only for studies whose status shows as "Expired" (see red box in screenshot below). For studies in other statuses, please see steps 1-7 above. 

10. Once in the study, click "Renew" from the right-hand menu (see purple box in screenshot below).

11. The system will automatically generate a renewal application. 

12. In Section A of the renewal application, select "Enrollment is closed" and "All research activities have been completed" for the first two questions (see blue box in screenshot below). 

• NOTE: The instructions will tell you to abandon the submission. Do not do this. 

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

• NOTE: In Section C of the application where the team is asked to "Summarize the research activities since last IRB approval" please start with the sentence "This is a closure request" to help the OIA analysts. 

14. Any documents to be submitted along with the closure (e.g. final DSMB report, final auditing report, etc.) can be included in the "Attachments" section of the Renewal Progress Report (see red box in screenshot below). 

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