Registering trials reduces research waste. It prevents duplication and means that more people can find out about studies to join.
Trusted information about health and social care studies should be publicly available for the benefit of all, and registration is the first step.
You can read more about this on our transparency pages.
All research should be registered in a publicly accessible database.
For clinical trials, it is a condition of a favourable ethics opinion. It is good practice for all other studies.
The Declaration of Helsinki says that 'Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject' and the International Committee of Medical Journal Editors (ICMJE) will only consider clinical trials for publication if they have been registered in an appropriate registry.
Registration of clinical trials
It is a condition of a Research Ethics Committee (REC) favourable opinion that a clinical trial is registered. You should register your trial before the first participant is recruited and no later than six weeks after. 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, please email the REC with your registration number to be added to the study records. You should ensure you keep the record in the registry up to date.
If you make amendments to your study, update the record in the registry as needed.
A ‘clinical trial’ is:
- a clinical trial of an investigational medicinal product
- a clinical investigation or other study of a medical device
- a combined trial of an investigational medicinal product and an investigational medical device
- any other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice.
Recognised registries include:
- International Standard Randomised Controlled Trial Number (ISRCTN) Registry which accepts prospective and retrospective registration of all clinical research studies. ISRCTN Registry is the preferred partner of the Department of Health and Social Care.
- ClinicalTrials.gov which accepts prospective and retrospective registration of medical studies in human volunteers.
- EU Clinical Trials Register which consists of information from the EU Clinical Trial Database, EudraCT. It accepts interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA) as well as clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development. For clinical trials (other than adult Phase 1 studies) involving both UK and EU sites, a record in the EU Clinical Trials Register will satisfy the REC favourable opinion condition for registration.
Registration of trials submitted through combined review
We’ve partnered with ISRCTN Registry to register trials submitted through combined review on behalf of sponsors.
All clinical trials of investigational medicinal products (CTIMPs) and combined trials of an investigational medicinal product and an investigational medical device (IMP/device trials) submitted on or after 1 January 2022 for combined review in the new part of IRAS are automatically registered on ISRCTN Registry.
Information will be sent directly to ISRCTN for registration. The lawful basis for processing the data for this purpose is official authority under the NHS Care Act 2014 (see our privacy notice). You should ensure that the record in the registry is kept up to date as the study progresses.
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. For more information about automatic registration, see the questions and answers pages.
CTIMPs and IMP/device trials submitted through combined review before January 2022 have not been automatically registered. Sponsors should register their trial according to the guidance above.
If you tell us that you have or will register on ClinicalTrials.gov then your study will not be automatically registered on ISRCTN.
Both ClinicalTrials.gov and ISRCTN registry feed in to Be Part of Research if UK locations are included, bringing us closer to having a full record of all UK clinical trials in one single place.
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. This is not a deferral request. Your study will still be registered on a public register and published on the research summaries of the HRA website. Where you have not included your ClinicalTrials.gov registration number in your IRAS application, please email it to the REC as soon as possible.
Registration of research tissue banks
It is a condition of 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. We monitor registration details as part of annual progress reporting. 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(s).
Publication of the research summary
We publish details about each research study reviewed by a REC in the UK in our research summaries database. Information is taken from the IRAS application that was reviewed by the REC. We publish:
- REC details: REC name, REC reference, REC opinion and date of REC opinion
- study identifiers: IRAS ID, registration numbers, Human Tissue Authority (HTA) storage licence (research tissue banks only)
- basic study information: short title, research type (for example, ‘research database’)
- contact name and email address
- full title
- research summary
- sponsor organisation name
- establishment organisation and address (research tissue banks and databases only)
- research programme (research tissue banks and databases only)
- samples or data collection arrangements (research tissue banks and databases only)
Deferral of registration on a public registry and publication of the HRA Research Summary
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.
The request to defer registration may also include a request to defer publication of the HRA Research Summary.
If you would like a copy of our full deferrals policy please email email@example.com
Deferrals are valid for 12 months. Sponsors can apply to extend by 12 months at a time.
A maximum deferral period now applies. Sponsors given approval to defer from 31 January 2022 onwards can continue to apply to extend the deferral period by 12 months at a time until the study comes to an end. They can then request to extend the deferral for another 12 months and then up to a further 18 months (a maximum of 30 months in total from the end of the study).
Deferral of research summary on the HRA website
Deferral of registration on a publicly accessible database (for clinical trials)
If a deferral is agreed we expect the sponsor to follow best practice and publish a minimal record on a publicly accessible registry (see After a deferral is agreed: Next Steps), 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 registry, to fulfil the condition of the REC favourable opinion.
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 all other studies, you can request a deferral by emailing firstname.lastname@example.org with the following information:
- IRAS ID and REC reference
- clear justification for the request
- whether the deferral request is for both research summary publication and registration (clinical trials) or whether the deferral is only for the research summary publication (non-clinical trials).
We’ll get back to you within five working days of relevant approvals (for example REC final opinion and HRA and HRCW Approval) being in place. Our email will confirm whether the deferral has been agreed and information about the deferral, including the end date.
After a deferral is agreed: Next Steps
For clinical trials, where deferral is approved after 31 January 2022, please follow best practice and register your trial on a publicly accessible registry -within six weeks of recruitment of the first participant -with minimum fields. When you have done this, email email@example.com to let us know the registration number.
Please also check whether there are any international regulatory requirements for registration of your clinical trial.
If you would like to request an extension to a deferral, email firstname.lastname@example.org at least ten working days before the end of the deferral period including:
- IRAS ID and REC reference
- clear justification for extending the deferral period
- whether the request to extend the deferral is for both research summary publication and registration (clinical trials) or whether the deferral is only for the research summary publication (non-clinical trials).
We will review requests on a case-by-case basis and will contact you within five working days to let you know whether the extension has been agreed, and the extended deferral end date.
At the end of the deferral we will publish the research summary in full on the HRA website. To meet the conditions of the REC favourable opinion, sponsors of clinical trials are responsible for ensuring that a full study record is available on a publicly available registry. Sponsors should email email@example.com to confirm this.
Where a deferral is agreed, minimal fields will still be published in the research summaries database, and clinical trials sponsors should follow best practice and register minimal fields on a publicly accessible database.
The minimum fields for research summaries of studies with a deferral are:
- REC name
- REC reference
- REC opinion
- date of REC opinion
- IRAS ID
- short title, title of the Research Tissue Bank or title of the Research Database
- study duration (for projects only, not applicable for Research Tissue Banks or Research Databases)
For clinical trials, where deferral is approved after 31 January 2022, 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 ISRCTN Registry website.
If you have questions about the deferrals policy or process, or would like to request a copy of the deferrals policy, email us firstname.lastname@example.org.
Project identifiers, including the IRAS ID
The IRAS ID is the unique identifier, which is generated by IRAS when you first create a project. The IRAS ID will be used by everyone involved in the project, whatever the type of health and social care research and the approvals required. Stakeholders across the UK have agreed to adopt the IRAS ID as the common study identifier. This will enable traceability across a whole study lifecycle - from funding through to delivery and dissemination. It will enable data sharing with organisations across the research landscape and streamline services for users. IRAS Help has more information. https://www.myresearchproject.org.uk/help/hlpirasid.aspx
All available project reference numbers should be entered into your IRAS dataset so that they may be included on your application form(s).
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