This section covers:
- Definitions of substantial and non-substantial amendments
- Preparing amendments
- Which review bodies need to approve or be notified of which types of amendments
Amendments are changes made to the research after review body approval has been given. The following sections provide information about each review body’s requirements and, where appropriate, guidance about how different types of amendments are handled by that review body.
Amendments requiring approval cannot be implemented until the relevant approvals are in place. Urgent safety measures should be implemented immediately and any subsequent notifications, including resulting amendments should be submitted, as appropriate and according to relevant guidance.
Please refer to ‘Navigating the review process’ for changes to an application that are required during the course of review by another review body.