1. HOW TO SUBMIT AN AMENDMENT TO A PROJECT THAT HAS ALREADY RECEIVED IRB APPROVAL Submitting an Amendment

2. Step 1: Select the Project to Amend After logging in to IRBManager, you will receive a list of all the projects you are currently associated. Click on the “Protocol Code” for the project you want to amend Click on the “Protocol Code” NOTE: If you have only one project you may be taken directly to the home page for that project.

3. Step 2: Find “Events” Section of Project Home Page “Events” Section

4. Step 3: Find Latest Version of Project For most investigators this is “Revisions Prior to Approval” Event Otherwise it is the “New Project” Event

5. Step 4: Select Latest Version of Project Select “New Project” or “Revisions Prior to Approval” by Clicking on the Name

6. Step 5: Select “xForms (1)” under ‘Actions’

7. Step 6: Select “Copy to Amend” Icon Click on the “Copy to Amend” icon (folder with a green circle) This creates a copy of the previous submission so you can make the changes where appropriate  Allows for a “complete” version of the project description at all times “Copy to Amend” icon is the folder with a green circle

8. Step 7: Select “OK”

9. Step 8: Select New Version You Created Click to select the new version NOTE: This will be titled “New Protocol Application” or “XXXXX” You can find the new version by looking at the “Started” date

10. Step 9: Answer Amendment Cover Page

11. Step 10: Make Necessary Changes After the Amendment cover page you will see a complete copy of your project submission. The fields are in an editable format, so you only need to make revisions where necessary.

12. Step 11: Complete Form and Submit for Approval Complete the remainder of the form as you would any other submission The PI will also need to authorize the request Department chair authorization is not required You will receive a notification when the amendment has been accepted into IRBManager for review You will receive a second notification when the amendment is approved. After receiving the approval letter you can implement the change into your research.

13. Questions? Contact Greg Manship, IRB Coordinator (317) 781-5774 or manshipg@uindy.edu