Guidance for health and social care researchers at the end of the Transition Period

The United Kingdom left the European Union on 31 January 2020. The Transition Period came to an end on 31 December 2020 and this page sets out what Sponsors need to do from 1 January 2021. Where relevant, we will also signpost to guidance from other relevant organisations.

Requirements for a Sponsor/legal representative

Clinical Trials of Investigational Medicinal Products (CTIMPs) taking place in the UK as well as any countries in the EU/European Economic Area (EEA), will already have a Sponsor or legal representative in the UK or EEA. The UK will continue to accept these arrangements as the EU/EEA are on the approved country list, so there is no need to amend the study in the UK.

Where a Sponsor chooses to change the Sponsorship of (or legal representative for) a CTIMP with sites in the UK to another legal entity (for example, one established in the EU/EEA), this would be a substantial amendment requiring submission to both Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC). Please see the information below about notifying the same amendment for a number of studies to REC.

For studies other than CTIMPs, the UK Policy Framework, does not require a UK legal representative of the lead Sponsor (or any co-Sponsor).

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 does not require an amendment to be notified in the UK (e.g. Sponsor’s legal representatives for CTIMPs and/or data Controller representatives for studies where the UK Sponsor is data Controller and their EEA sites are processing personal data on their behalf). Similarly, no amendment is required in the UK to establish any arrangements solely in relation to the study’s management and conduct outside the UK that do not affect the approved UK study.

Where the Sponsor is from the rest of the world and the legal representative is established in the UK and there are sites in the EU/EEA, the Sponsor will need to assign a 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.

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, 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 the next amendment summitted to the REC.

If the change means personal data of UK participants will be transferred outside the UK, information to participants will need to be updated and a substantial amendment will be required. Please refer to our guidance on use of data at end of transition and our guidance on GDPR transparency.

Changes to IMP, drug, device or radioisotopes

Any changes, not within scope of the original or amended approval, to IMPs, drugs, devices or radioisotopes used in research should be notified as substantial amendments requiring submission to both MHRA and REC.

Submitting amendments

Sponsors amending a study in line with the advice above should submit in the usual manner using the amendments tool and online submission through IRAS. Guidance is provided below for amendments that are non-substantial and do not require study-wide review and for amendments that apply across all studies for a Sponsor.

Amendments that are non-substantial and do not require study-wide review

On completing the amendments tool, all amendments should be submitted in accordance with the guidance provided in the tool. For amendments that are non-substantial and do not require study-wide review, these should be submitted via the online submission and 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 amendments@hra.nhs.uk, providing the following information:

A covering letter explaining what change is needed.
Evidence that the change has been accepted in the company or organisation.
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.

CTIMP submissions to MHRA from 1 January 2021

Full guidance on substantial amendments to a CTIMP including changes to the trial Sponsor/legal representative, Investigational medicinal product certification and importation and amendments that need to be reported to the Medicines and Healthcare products Regulatory Agency can be read on gov.uk

Sponsors wishing to make CTIMP submissions (initial applications, substantial amendments, end of trial notifications and developmental safety update reports (DSURs) to MHRA from 1 January 2021 will need to use 'MHRA Submissions'. Further guidance, including how to register, is provided on gov.uk

Use of Data at the end of the transition period

The latest information on data transfer and legal requirements at the end of the transition period is being published by the ICO.

The Government has announced that the Treaty agreed with the EU will allow personal data to flow freely from the EU (and EEA) to the UK, until adequacy decisions have been adopted, or for no more than six months.

This will enable organisations across all sectors to continue to freely receive data from the EU (and EEA).

As previously announced, the UK has, on a transitional basis, deemed the EU and EEA EFTA States to be adequate to allow for data flows from the UK.

Important information for Non-public bodies: If you are not a public body and are the Controller for a trial processing personal data in the EU, you should put in place a representative in the EU, if you have not already done so.

The UK is England, Scotland, Wales, and Northern Ireland. It does not include Crown dependencies or UK overseas territories, including Gibraltar. The UK government will allow transfers to Gibraltar to continue.

If your transfer of personal data is outside UK and not to the EEA, you should already have considered how to comply with the GDPR data transfer requirements. You will continue to be able to rely on the same mechanisms, for example adequacy decisions, binding corporate rules or standard contractual clauses.

Detailed operational guidance will be provided in the coming months, including updated model trial agreements and arrangements for changes to participant information.

Registration of clinical trials and the publication of results

Any favourable opinion given by a UK Research Ethics Committee for a clinical trial (a clinical trial is defined as the first four categories in IRAS) is subject to the trial being registered on a publicly accessible database. This will not change from 1 January 2021.

The HRA has made a commitment in its Make It Public research transparency strategy, in the long term, to register clinical trials on behalf of sponsors and researchers. We’ve partnered with ISRCTN Registry to register clinical trials of investigational medicinal products (CTIMP) on behalf of sponsors. CTIMPs submitted on or after 1 January 2022 for combined review in the new part of IRAS are automatically registered on ISRCTN Registry. Sponsors should register all other UK clinical trials on an established international register such as the ISRCTN registry, or ClinicalTrials.gov, to ensure the public is aware of the trial.

You can find more information about registration on the HRA website.

Further information from regulatory authorities on the EU transition can be found here:

MHRA on CTIMPs - approved countries where a clinical trial Sponsor, or their legal representative, may be established
MHRA guidance – requirements for supplying IMP to Northern Ireland
MHRA guidance on the Regulation of medical devices from 1 January 2021
Human Tissue Authority (HTA) Transition guidance
FAQs on HTA licensing requirements for human tissues and cells used in clinical trials and medicines