Guidance

Registration of clinical trials for investigational medicinal products and publication of summary results

This guidance contains information about registration of clinical trials, publishing trial results and requirements.

From:
Medicines and Healthcare products Regulatory Agency
Published
31 December 2020

This guidance was withdrawn on

The information on this page is no longer up to date. Up to date information can be found on our main page and the Health Research Authority’s page.

Registration of your clinical trial

Actions for those involved in registering clinical trials

You should use existing and established international registers such as ISRCTN registry, or ClinicalTrials.gov, to ensure the public is aware of your trial. For trials involving both UK and EU sites a record in the EU Clinical Trials Register will exist (other than adult Phase 1 studies).

In the UK, any favourable opinion given by a research ethics committee is subject to the condition that the clinical trial is registered on a publicly accessible database. Registration should occur before the first participant is recruited and no later than six weeks after recruitment of the first participant. This has not changed. You should continue to include the registry number, if available, in the Integrated Research Application System (IRAS) when you prepare your application.

If a sponsor wishes to request a deferral of study registration within the required timeframe, in accordance with current transparency rules (e.g. due to commercial sensitivity), they should contact the Health Research Authority (HRA) at study.registration@hra.nhs.uk.

The UK makes information about trials being conducted in the UK available to the public, patients, researchers and clinicians via the HRA research summaries website and UK “Be Part of Research” website.

Publishing trial results

The time frame for publishing the summary of results is within 6 months of the end of trial for paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials.

Actions for those publishing results

You should publish your summary results within these timeframes in the public register (or registers) where you have registered your clinical trial.

You do not need to submit this clinical trial summary report to the MHRA as well; however, you must send a short confirmatory email to CT.Submission@mhra.gov.uk once the result-related information has been uploaded to the public register and provide a link. If your clinical trial is not on a public register, summary results should be submitted to the MHRA.

You should also submit a final report to the Research Ethics Committee within the same timeframe for reporting the summary of results.

Future requirements

We will communicate further on any longer-term requirements for registration and reporting of trials.

Clinical Trials webinar recording which took place on 21 October 2020:

Clinical Trials webinar recording which took place on 21 October 2020

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. You can also email clintrialhelpline@mhra.gov.uk with urgent questions. Alternatively, contact your Trade Association by emailing:

Published 31 December 2020
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