Registering your research

The UK Policy Framework for Health and Social Care Research states the importance and requirements of registration:

Where you need to register your clinical trial

You need to register your clinical trial on a publicly accessible database.

This means any registry on the World Health Organisation (WHO) list of primary registries or the International Committee of Medical Journal Editors (ICMJE) list of registries that facilitates public access to information about the UK trial.

We ask sponsors to use either ISRCTN or ClinicalTrials.gov as these both feed in to Be Part of Research. This is a free service which makes it easy to find and take part in vital health and care research across the UK.

This also helps bring us closer to having a full record of all UK clinical trials in a single place.

Please note that for trials taking place in both the EU and the UK, registration with the EU Clinical Trials Information System (CTIS) will not satisfy the condition for registration as it does not support visibility of UK trials. Furthermore, CTIS is currently a ‘data provider’ to the WHO and not a primary or ICMJE approved registry.

How to know if your research is a clinical trial

A ‘clinical trial’ is:

• a clinical trial of an investigational medicinal product (CTIMP)
• a clinical investigation or other study of a medical device
• a combined trial of an investigational medicinal product and an investigational medical device (see information on Combined Review)

It can also be any other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice, for example research involving:

• trials of surgical interventions
• radiotherapy
• imaging investigations
• mental health investigations or therapies
• physiological investigations
• trials of products not defined as medicines or medical devices (for example nutritional)
• complementary or alternative therapies

When to register your clinical trial

You should register your trial before the first participant is recruited, and no later than six weeks after.

What details you should include when registering your clinical trial

If your trial is already registered when you complete your IRAS application, you should include your registration number.

If you register after submitting your IRAS application, you should email the Research Ethics Committee and deferrals@hra.nhs.uk with your registration number as soon as possible.

You should ensure you keep the record in the registry up to date.

If you make amendments to your study, you must update the publicly accessible record as needed.

What happens if you abandon the clinical trial

If you decide to abandon a clinical trial before it commences (before any trial procedures such as patient screening or consent set out in the protocol have been initiated), then the trial will not need to be registered.

The process for registering a trial submitted through Combined Review

If you submitted your research application through Combined Review, then your study information will be sent directly to ISRCTN for registration on your behalf. This is due to a partnership we have with them to make the process easier for you.

This is the case for all clinical trials of investigational medicinal products (CTIMPs) and combined trials of an investigational medicinal product and an investigational medical device (IMP device trials).

ISRCTN will be in touch with you to ask for some additional information to finalise the registration. ISRCTN will also let us know the registration number for your trial, so you don’t need to email us.

You should still make sure that the record of your trial in the registry is kept up to date as the study progresses.

Find out more about our partnership with ISRCTN.

Find out more about the information we share with ISRCTN registry.

What to do if you have already registered or plan to register your trial on ClinicalTrials.gov

If you tell us that you have registered with ClinicalTrials.gov or that you would prefer to register your clinical trials here, then you can request that your study is not registered with ISRCTN.

To let us know that you have or will register on ClinicalTrials.gov, you’ll need to make this clear in your IRAS application. You should do this in ‘section c’ of the study information section of your Combined Review application in IRAS.

If you have not included your ClinicalTrials.gov registration number in your IRAS application, you should email it to the REC and deferrals@hra.nhs.uk as soon as possible.

Registration of research tissue banks

It is a condition of a favourable ethics opinion that all research tissue banks are registered on the UK Clinical Research Collaboration (UKCRC) Tissue Directory.

The research tissue bank should be registered no later than six weeks after favourable opinion, or six weeks after the research tissue bank holds tissue with the intention to provide for research purposes.

Registration means having added details of the types of tissue samples held in the tissue bank. Your research registration reference number should be entered in your dataset on the Integrated Research Application System (IRAS), so that this can be included on your application form.

See the Research Tissue Bank webpage for further information.

Information about your clinical trial that is shared on the HRA website

We publish details of all research in the UK that is reviewed by a REC or seeking HRA approval in the research summaries section of our website.

This includes information about the planned research, a summary of the research as submitted to the REC, and the REC’s opinion.

We also publish details of all applications approved by the Confidentiality Advisory Group (CAG) in the CAG registry. This contains summary information about the activity, details of the identifiers approved and applicant contact details.

If you choose to defer your study, we will still publish a minimum research summary. At the end of the deferral period, we will publish the full  research summary.

This information is pulled through from your research application page on IRAS.

How to defer registering your research

We recognise that commercial sensitivity may be a concern in some sectors and so it is possible for applicants and sponsors to submit a request to defer registration of clinical trials on a publicly accessible database.

You can also request to defer publication of information about your trial in the Research Summary section on the HRA website, as described above.

This can be included in a request to defer registration or requested separately.

How to request a deferral

If you are using Combined Review, you can submit a deferral request in the new part of IRAS, by answering the deferral question in ‘part c’ of the study information question set.

For other clinical trials not submitted via combined review, you can request a deferral by emailing deferrals@hra.nhs.uk with the following information:

• IRAS ID
• REC reference
• clear justification for the request

We will confirm whether the deferral has been agreed and provide information about the deferral, including the end date.

If you would like to request an extension to a deferral, you should email deferrals@hra.nhs.uk at least 10 working days before the end of the deferral period and include:

• IRAS ID
• REC reference
• clear justification for extending the deferral period

We will review requests on a case-by-case basis and will contact you to let you know whether the extension has been agreed and the extended deferral end date.

Deferral validity

Deferrals are valid for 12 months.

Sponsors can continue to apply to extend the deferral period by 12 months until the study comes to an end. You can then request an extension of the deferral for a specified period, up to a maximum of 30 months in total from the end of the study.

The definition of the end of the study should be documented in the protocol. For most clinical trials, this will be the date of the last visit of the last participant.

Where a deferral is agreed we:

• expect the sponsor to publish a minimal record on a publicly accessible registry
• when the deferral period ends, the sponsor should publish the full record on the same registry, to fulfil the condition of the REC favourable opinion
• when you have done this, email deferrals@hra.nhs.uk to let us know the registration number
• will publish a minimum research summary on the research summaries section of the HRA website

Publishing information on your clinical trial if it is deferred

If a deferral is agreed, we expect the sponsor to follow best practice and publish a minimal record on a publicly accessible database. This applies to any deferrals approved after 31 January 2022. When the deferral period ends, the sponsor should publish the full record on the same publicly accessible database, to fulfil the condition of the REC favourable opinion.

The HRA will not publish the summary results on the research summaries pages.

For clinical trials, where a deferral is approved, the minimum information that we expect to be published on a registry is:

• registry number
• IRAS ID
• investigator name and site address
• sponsor name and address
• REC decision and date of decision
• nature of clinical trial (for example, bioequivalence in 24 healthy volunteers)
• date of start of trial
• date of end of the trial in the UK, EU member states (if applicable) and globally (if applicable)
• date of start of recruitment
• date of end of recruitment
• justification of deferral

There is more information about registering clinical trials with minimum fields on the ISRCTN Registry website.

More information on deferrals

If you have questions about our deferrals policy or process, email deferrals@hra.nhs.uk