HRA-ISRCTN Registry partnership - questions and answers

Registration of clinical trials is a condition of a Research Ethics Committee (REC) favourable opinion, but an audit by the HRA shows that more than ten per cent of clinical trials fail to do this. Automatic registration means that information about all new trials approved through combined review will be publicly available for the benefit of all. 

We carried out an options appraisal to find the best registry solution for UK researchers and decided to partner with ISRCTN Registry for the automatic registration of clinical trials.

ISRCTN is a UK-based publicly accessible registry recognised by the World Health Organisation (WHO) as a primary clinical trials registry. It is also recognised by ICMJE. This means that registration with ISRCTN Registry meets the condition of a REC favourable opinion.

All studies registered on ISRCTN that include UK sites, or registered on ClincialTrials.gov (excluding deferred studies) appear on the Be Part of Research website, which is delivered by the NIHR on behalf of the Department of Health and Social Care with the aim of increasing the public’s access to research.

If a trial approved through combined review is registered or will be registered on ClinicalTrials.gov, you can request that it is not automatically registered with ISRCTN. 

Both ClinicalTrials.gov and ISRCTN feed in to Be Part of Research. We are asking sponsors to use one of these to bring us closer to having a full record of all UK clinical trials in one single place. 

Having these options will make registration easier for sponsors and applicants and reduce the burden of having to maintain records on multiple registries.

If a trial approved through combined review is registered or will be registered on ClinicalTrials.gov, you can request that it is not automatically registered with ISRCTN.  

We ask sponsors to use either ISRCTN or ClinicalTrials.gov as both feed into Be Part of Research. This will bring us closer to having a full record of all UK clinical trials in one single place.

For clinical trials (other than adult Phase 1 studies) involving both UK and EU sites, a record in the EU Clinical Trials Register would still satisfy the REC favourable opinion condition for registration, but would not help us to ensure full details of the trial is visible to the general public.

Now that the UK has left the EU, the UK national competent authority no longer has access to EU Clinical Trial Register or EU Clinical Trials Information System and can’t upload details for UK trials into these databases. UK CTIMPs will no longer appear in the EU Clinical Trials Register or the EU Clinical Trials Information System.

Automatic registration started on 1 January 2022 for trials submitted for combined review in the new part of IRAS. Clinical trials of investigational medicinal products (CTIMP) and combined trials of an investigational medicinal product and a medical device (IMP/device) will be included.

The service will be rolled out to other types of clinical trials in time.

Automatic registration is currently only planned for clinical trials.

Clinical trials are defined as:

• clinical trial of an investigational medicinal product
• clinical investigation or other study of a medical device
• combined trial of an investigational medicinal product and an investigational medical device
• other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice.

Automatic registration will apply to all clinical trials, irrespective of the funding source.

There is no charge to sponsors or researchers for automatic registration under an agreement between the HRA, the Department of Health and Social Care and ISRCTN Registry. This applies to both commercial and non-commercial sponsors.

Registration will only be free for trials using combined review, via the new part of IRAS, that were submitted on or after 1 January 2022 and automatically registered by the HRA.

There is a process in place to ensure that no study is registered twice on ISRCTN.

If a trial is or will be registered with ClinicalTrials.gov you can request not to be registered on ISRCTN registry.

We will register the clinical trial on ISRCTN, if it is registered on any other registry.

We ask sponsors to use either ISRCTN or ClinicalTrials.gov as both feed in to Be Part of Research, bringing us closer to having a full record of all UK clinical trials in one single place.

You can tell us about your ClinicalTrials.gov registration by selecting the appropriate option in your IRAS application (study information, section C).

We ask sponsors to use either ISRCTN or ClinicalTrials.gov as both feed in to Be Part of Research, bringing us closer to having a full record of all UK clinical trials in one single place.

From 31 March, you can ask us not to register your trial on ISRCTN by selecting the appropriate option in your IRAS application (study information, section C). You can also choose to register on both ClinicalTrials.gov and ISRCTN.

The HRA will automatically register your clinical trial with ISRCTN, starting with those submitted via combined review unless:

- you request to defer registration and this is approved

- the trial is registered or will be registered with ClinicalTrials.gov and you request not to be registered on ISRCTN Registry.

Having your trial already registered on any other registry, will not be accepted as a reason for deferring registration with ISRCTN. You can still register your trial on another registry.

Registration on ISRCTN will meet the condition of a favourable REC opinion so there is no need to register elsewhere, unless you need to do so to meet requirements set by other organisations or regulatory bodies for your trial.

No. Only trials processed through combined review in the new part of IRAS after 1 January 2022 will be automatically registered. ISRCTN registration through CPMS will continue to be available and should be used by all other study types.

For more information on registering on ISRCTN Registry via CPMS and accessing NIHR Clinical Research Network support, please visit the NIHR website.

Trials submitted for combined review through the new part of IRAS can request to defer registration and publication of the research summary on the HRA website using the new question in IRAS. You can find further guidance on the HRA website.

If a deferral is agreed by the HRA, then the study will not be automatically registered on ISRCTN. However, the sponsor will be expected to contact ISRCTN to register minimum fields and obtain a registration number.

Registration of the minimum fields after the HRA has approved deferral will be free to sponsors. Full registration with ISRCTN will also be free to sponsors when the deferral period comes to an end, but this will not be done automatically.

You are still required to register your trial on a publicly accessible registry. You will need to arrange this yourself, either by approaching the registry directly or via the NIHR's Central Portfolio Management System (CPMS). All studies eligible for NIHR CRN support are able to register on ISRCTN Registry via CPMS. Non-commercial studies with an interventional component taking place in England qualify for free ISRCTN registration

Automatic registration applies to CTIMPs and combined IMP/device trials submitted through the new part of IRAS from 1 January 2022. The HRA will not be registering any clinical trials submitted before this date.

Automatic registration by the HRA will fulfil the condition of a REC favourable opinion.

Automatic registration on ISRCTN will happen after all approvals are in place. You will be contacted by ISRCTN after making your application through IRAS, to provide some additional information that is currently not available in the IRAS application form. These are listed in this data table. ISRCTN will confirm when registration has been completed and will issue a registration number. ISRCTN will inform the HRA of the registration number.

We will automatically register your trial with ISRCTN when all approvals are in place. If a trial is registered with ClinicalTrials.gov you can request not to be registered on ISRCTN Registry.

If you want to register your trial earlier (sometimes known as prospective registration), before overall approval for the trial is received, you will need to contact ISRCTN directly to arrange this. You may want to wait until after you have submitted your trial via IRAS as ISRCTN will then have your study details available.

If we automatically register your trial, then ISRCTN will confirm registration and pass on the registration number to the HRA and NIHR CRN.

 If you register on any other registry, you’ll need to send the registration number to the REC as soon as possible.

The data submitted in your IRAS application that will be shared with ISRCTN is listed in this table

A data sharing agreement between HRA and ISRCTN Registry is in place.  This data sharing agreement will specifically ensure that both parties are aware of and signed up to delivering their obligations under the GDPR.

The lawful basis for processing your personal data for the purpose of automatic registration is official authority under the NHS Care Act 2014 (for further information please see our privacy notice).

HRA’s system extracts the required data from IRAS which is sent in a format that is encrypted and password protected. This is sent to a secure ISRCTN server.

The lay summary of your study will be taken from the IRAS application. ISRCTN Registry may suggest edits to this for agreement with the applicant in order to create a plain language summary that uses the ISRCTN format and style.

The lay summary of your study will be promoted to members of the public through the Be Part of Research website, which the NIHR delivers on behalf of the Department of Health and Social Care.

No, you should ensure your record in the registry is kept up to date as the study progresses. It’s the sponsor’s responsibility to ensure the record in the registry is updated when there are amendments made to the study.