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Handling of amendments in a no-deal Brexit: HRA guidance

Last updated on 6 Mar 2019

Changes relating to sites outside the UK

If you are a sponsor based in the UK running a multi-national study, you may need to consider arrangements relating to sites outside the UK. Assigning additional representatives in the EU (e.g. sponsor’s legal representatives for drug trials, GDPR representatives) or establishing any arrangements solely in relation to the study’s management and conduct outside the UK that do not affect the approved UK study do not need to be notified as substantial amendments in the UK.

Sponsor/legal representative

No amendment is required where the sponsor or legal representative for an ongoing trial is established in the EU/EEA (outside the UK), as the UK will continue to accept this. Where the sponsor is from the rest of the world and the legal representative is established in the UK and there are sites elsewhere in the EU/EEA, the sponsor will need to assign an EU/EEA legal representative in the EU/EEA for these EU/EEA sites.  No amendment will need to be submitted in the UK in this scenario if the sponsor retains the UK legal representative for the UK study. Similarly, no amendment will need to be submitted in the UK if the sponsor remains in the UK and a legal representative is added to cover EU/EEA sites. 

A change in sponsor or legal representative is a substantial amendment requiring submission to both MHRA and REC. Please see the information below about notifying the same amendment for a number of studies to REC.

Changes to suppliers, archiving facilities or laboratories affecting UK sites

Any change in supplier or central laboratory may be implemented as a non-notifiable amendment to the REC, if it does not affect participant-facing information. The amendment should be recorded at sites with the updated version numbers of any documents, and implemented at sites. The updated documents should be referenced in a subsequent amendment.

If the change means personal data of UK participants will be transferred outside the UK, information to participants will need to be updated. See the guidance on GDPR transparency.

Changes to IMP, drug, device or radioisotopes

Any changes to IMPs, drugs, devices or radioisotopes used in research should be notified as substantial amendments.

Non-notifiable amendments

If the only participating sites are in England and Wales, a non-notifiable amendment can be implemented immediately with sites, without submission to HRA or HCRW. 

If there are participating sites in Scotland and Northern Ireland, a non-notifiable amendment should be sent to the relevant permissions coordinating centre via the Lead Country to be distributed to the relevant R&D offices. The amendment can be implemented immediately with sites.

Submitting amendments impacting a number of studies to REC

Where the same amendment will apply across a number of studies managed by a particular sponsor, it is possible to request that the amendment is submitted once for all studies as opposed to an individual amendment being prepared for each application. The amendment should be submitted to hra.amendments@nhs.net, providing the following information:

1.    A covering letter explaining what change is needed.

2.    Evidence that the change has been accepted in the company or organisation.

3.    A list of open impacted studies with IRAS ID, study title, and participating nations (England, Scotland, Wales, Northern Ireland).

For detailed guidance on submitting amendments please see IRAS

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