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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.
