Key changes to UK amendment process

The devolved administrations, the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have agreed to make two key changes to the UK amendment process with effect from 25 March 2021.

Firstly, the addition of a new NHS/HSC site or a change of PI at an NHS/HSC site for a Clinical Trial of an Investigational Medicinal Product (CTIMP) study will now be classified as a Non-Substantial Amendment*. This was previously considered a Substantial Amendment.  The change is designed to speed up new site set up. This is possible because new sites were categorised as substantial due to EU guidance and therefore, from January 2021, we can take a different interpretation for NHS/HSC sites due to the UK system in place.

The amendment tool will provide the appropriate categorisation and guidance on the next steps to take. The Standard Operating Procedures for Research Ethics Committees have also been updated to reflect this change.  There is no change to the classification of amendments relating to new sites/change of PI at non-NHS sites in CTIMP studies.

Secondly, the amendment tool can now be used to notify MHRA of substantial amendments in place of the Annex 2. This should save applicants time by reducing the number of forms to be completed. The Annex 2 may still be used to notify the MHRA of ‘bulk’ amendments (identical changes to multiple studies at one time) and will be available on the MHRA website.

The amendment tool has been updated and the new version (V1.5) is now available. A short video has been produced on how to complete the tool. (You will need to first register on the HRA’s Learning Management System and then follow the link to the video). If you have any further questions, contact amendments@hra.nhs.uk for support.

It is important to use the latest version of the tool otherwise your amendment may be incorrectly categorised. Please check for the latest version before submitting each amendment.

All four UK nations are working together to improve the amendments process. The introduction of the excel-based amendment tool provides the opportunity to test an approach that tailors guidance to the individual amendment. In the longer term, this will be incorporated into new functionality in IRAS - making submission and approval of amendments quicker and easier for everyone involved.  You can provide feedback on the amendment tool using our online survey.

*Submitting Non-Substantial Amendments

Upon submission of either a Non-Substantial or Non-Substantial, No Study-wide Review amendment, you will receive a system generated confirmation email. You should then follow the guidance in the amendment tool on how to communicate the amendment to the participating site(s) as this will vary depending on where the sites are located and the categorisation of the amendment (A, B or C).