Amendments post approval

Amendments 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

• Project-based research should now prepare amendments using the Amendment Tool.

• Amendments should be submitted for review via online submission.

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.

Adding new site(s)

If you are adding a site that is in a nation not previously involved in the project, you should indicate this at the relevant question of the Amendment Tool and make this clear in the covering letter when submitting your amendment to the lead nation.

You do not need to provide an updated IRAS Form Part C alongside an amendment to add a new NHS/HSC site. You should list the names of the new sites in the description of amendment box in the Amendment Tool.

If your study is a CTIMP (Clinical Trial of an Investigational Medicinal Product) you will need to submit a substantial amendment .

If your study is a non-CTIMP (non-Clinical Trial of an Investigational Medicinal Product) you will need to submit a non-substantial amendment .

The guidance on this page does not apply to:

• • Research Tissue Banks (RTB) and Research Databases (RDB) as these do not need NHS/HSC R&D Permission or HRA Approval;

  • Urgent Safety Measures. These should be sent to all participating organisations on receipt to ensure the participants' safety. Subsequent notifications, including resulting amendments should be submitted, as appropriate and according to relevant guidance; or

  • Notifications of the end of a study. These are not amendments and should be notified using the appropriate Notice of End of Study form.