The amendment process involves updating the application with the changes to the study. After the amendment is approved, the new version incorporates the original and all approved amendments.
An application can only have one amendment or one renewal in progress at a time.
From the “Manage Protocols” screen, open the application you want to amend.
Select the “Amend” button from right-hand menu.
Enter the reason for the amendment in the Amendment Justification box and select “Continue.”
If the buttons are greyed out, there is likely another amendment or renewal in progress, or you are not on the latest approved version of the application.
Open the Version screen and check for an in progress version and the latest approved version to see the current state of the application.
