Kuali IRB Quick Sheet - Steps to Submitting an Amendment


During the course of the conduct of a study it may be necessary to make changes to the study. These might be due to new personnel, unexpectedly high screen failure rates, changes to minimize risks, addition of new recruitment materials, as well as a whole host of other reasons. Changes to an IRB approved study must receive IRB approval prior to implementation unless the change is made to eliminate an apparent immediate hazard to a subject. This KBA walks users through how to submit an amendment in Kuali IRB. 

Steps to Take 

1. Start by logging in to Kuali IRB.

2. Find the study you wish to submit an amendment 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 "Amend" from the right-hand menu (see purple box in the screenshot below).

4. A pop-up box will open in the screen. Select the check boxes for the sections of the Kuali application for which you wish to make changes (e.g. if changing study personnel click the box for "Project Basics/Study Personnel" or if changing, adding, or removing documents click the box for "Supporting Information"). These are indicated in the orange box in the screenshot below. Then click "Done" at the bottom of the pop-up box (see blue box in screenshot below).

5. The system will automatically generate an amendment application.

6. At the top of the amendment application will be a number of questions to be answered (see red box in screenshot below), based on whether the study is being reviewed by an external IRB or not, that help the IRB understand what the changes are and why they're being requested. You'll also see the sections on the left-hand side of the screen which are available for editing denoted by a green circle with a lightning bolt symbol (see green box in screenshot below).

7. Complete the questions at the top of the amendment application and then proceed through the Kuali application making the relevant changes. 

8. If you are changing, adding, or deleting documents as a part of the amendment, follow these instructions:

9. Sometimes when making changes to parts of the Kuali application a team member may realize that they didn't "unlock" all the sections they need to change or new sections of the Kuali application have appeared that need to be completed (e.g. adding children as a subject population that will be specifically recruited). If this happens, click "Add/Remove Section" from the right-hand menu in Kuali (see red box in screenshot below). Complete the actions in Step 4 above to add the additional sections that need to be revised/completed to the amendment. 

10. Once the amendment application questions have been answered and all changes have been made. Click "Submit" from the right-hand menu to submit the amendment to OIA for review (see green box in screenshot below).