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Managing amendments Amendments prior to approvalThe below guidance applies to research projects with NHS/HSC R&D Permission or HRA Approval only. If your study does not yet have these, please refer to IRAS Help pages for seeking NHS/HSC R&D Permission or HRA Approval .
Amendments post approvalAmendments are changes made to a research project after approval has been given. If you plan to make an amendment to your research project, you need to determine whether you need to notify the review bodies from whom you have received approvals.
It is the sponsor’s responsibility to decide whether an amendment is substantial or non-substantial. The HRA provide examples of substantial and non-substantial amendments .
Detailed guidance on submission, categorisation and implementation of amendments can be found at HRA Amending an approval and the IRAS amendments help section .
On 2 June 2020 changes were introduced to the way amendments are notified to Research Ethics Committees and NHS/HSC
The tool replaces the Substantial Amendment Notification Form, and Non-Substantial Amendment forms for non CTIMPs. For CTIMPs, the EudraCT Annex 2 amendment form will still be required and can be completed within the Amendment tool.
Guidance available on the IRAS portal and an instructional video on how to submit amendments online
For support and queries about the new tool and online submission please contact amendments@hra.nhs.uk for support.
On receipt of the categorisation email, the research team should forward this along with the amendment documents to participating NHS sites and research offices so that, where necessary, arrangements can be put in place to confirm the site’s continued capacity and capability or, for addition of a new site, confirmation of capacity and capability.