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

HOW TO SUBMIT AN AMENDMENT TO A PROJECT THAT HAS ALREADY RECEIVED

IRB APPROVAL

Submitting an Amendment

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.

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

“Events” Section

Step 3: Find Latest Version of Project

For most investigators this is “Revisions Prior to Approval” Event

Otherwise it is the “New Project” Event

Step 4: Select Latest Version of Project

Select “New Project” or “Revisions Prior to Approval” by Clicking on the Name

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

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

Step 7: Select “OK”

Step 8: Select New Version You Created

Click to select the new versionNOTE: This will be titled “New Protocol Application” or “XXXXX”

You can find the new version by looking at the “Started” date

Step 9: Answer Amendment Cover Page

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.

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 requestDepartment chair authorization is not

requiredYou 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.

Questions?

Contact Greg Manship, IRB Coordinator(317) 781-5774 or [email protected]