A new Modification Tool has been released to help sponsors and researchers prepare for updated clinical trials regulations which come into force on 28 April 2026.
We’ve renamed and updated the tool to reflect the change in terminology from ‘amendment’ to ‘modification’ and the new modification types in the regulations, which apply to clinical trials of investigational medicinal products (CTIMPs).
Non-CTIMP studies will also adopt the same change in terminology for modifications and modification categories.
The Modification Tool will help sponsors and researchers of both CTIMPs and non-CTIMPs to process modifications and will provide guidance on which review bodies the modification should be sent to, based on the changes that are being made to a project.
The tool is currently only available for information purposes so the research community can familiarise themselves with the updated version. It will become fully operational on 28 April 2026 and can be included in modification submissions from that date.
Updates to the tool
The functionality and terminology within the tool have been updated in line with the new regulations to include the following types of modification:
- substantial modification
- modification of an important detail
- minor modification
- non-notifiable
Functionality and guidance relating to modified amendments has been removed as the introduction of the request for information process removes the option to submit a modified amendment.
We’ve also updated the tool to clearly show if a governance review for implementation of a modification at participating NHS and/or health and social care (HSC) organisations is expected or not expected.
Aligning the tool with our new digital service
We are developing a new digital service, Plan and Manage Health and Care Research, which will allow users to plan and prepare new research and make changes to existing research in a seamless way.
The new service will eventually replace the Modification Tool and other legacy services that sponsors and researchers currently use for submitting CTIMP and non-CTIMP modifications.
We have made sure that the options available for selection in the Modification Tool align as closely as possible with those that will be available in the new service. This will help to support a smooth transition as more projects migrate to the new service.
For a full picture of the options available for selection, we advise users to check the ‘glossary of options’ tab in the Modification Tool.
Guidance for using the Modification Tool
Guidance has been built into the tool itself to help sponsors and researchers navigate the updated functionality and terminology, and we’ll also update our Step by step guide to using IRAS for Combined Review which includes information for submitting CTIMP modifications.
For some of our legacy systems, including those that support online submissions of modifications, we will not be updating them ahead of the roll-out of Plan and Manage Health and Care Research. Our Modification Tool therefore includes lots of guidance on how to submit modifications in the right way based on the options available within the legacy systems.
Using the Modification Tool before and after 28 April 2026
Up until 27 April 2026, the Modification Tool will have limited functionality. Sponsors and researchers can download the new version of the tool in Microsoft Excel, explore the functionality and prepare modifications for submission on or after 28 April 2026. The built-in functionality of the tool will not allow a locked PDF copy to be generated for the submission of a modification.
From 28 April 2026, the full functionality of the Modification Tool will go live. This means that sponsors and researchers will be able to use the built-in lock functionality and generate a PDF as part of the modification submission process.
Submitting amendments before 28 April 2026
If an amendment needs to be submitted before 28 April 2026, the Amendment Tool (version 1.8) on IRAS Help should be used.
This version of the tool will be removed from IRAS Help on 28 April 2026.
Submitting modifications for CTIMPs from 28 April 2026
From 28 April 2026, the Modification Tool must be used for all CTIMP modifications to comply with the amended regulations.
Submitting modifications for non-CTIMPs from 28 April 2026
Sponsors and researchers are encouraged to use the Modification Tool for non-CTIMP modifications from 28 April 2026.
The Amendment Tool (version 1.8) will be removed from IRAS Help on 28 April 2026.
Where sponsors and researchers have downloaded a copy of the Amendment Tool (version 1.8) before 28 April 2026 and are already working on this version to prepare a modification submission, we will continue to accept these for non-CTIMPs up until 29 May 2026.
The Modification Tool should be used for all non-CTIMP modifications from 30 May 2026.
Questions
If anyone has questions or comments about the Modification Tool, or for support with using the tool, please get in touch with us at amendments@hra.nhs.uk