Key changes to UK amendment process for clinical trials

The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have implemented two changes to the UK amendment process for clinical trials from 25 March 2021.

These changes have been implemented following the end of the transition period and represent the latest developments in the management of clinical trials in the UK.

The first change stipulates that for clinical trials of an investigational medicinal product (IMP), the addition of a new National Health Service (NHS)/Health and Social Care (HSC) site or a change of Principle Investigator (PI) at an NHS/HSC site will now be classed as a non-substantial amendment. Since this was previously classified as a substantial amendment under European Union (EU) guidance, the change to the amendment process only applies to NHS/HSC sites.

The second update to the amendment procedure details that sponsors can use the amendment tool to notify the MHRA of substantial amendments. This replaces the European Commission “Annex 2” form (substantial amendment notification form). However, the form is still available on the MHRA website and can be used for amendments where the same change will affect many trials simultaneously. It is important to use the latest version of the amendment tool to avoid incorrect categorisation of an amendment.

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