This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

HRA-ISRCTN Registry partnership - questions and answers

  • What’s changing?

    From 1 January 2022 the HRA will automatically register clinical trials of investigational medicinal products (CTIMP) that are submitted through combined review in the new part of IRAS with ISRCTN Registry. This is one of the steps to ensure research transparency. It is still a standard condition of a Research Ethics Committee (REC) favourable opinion for clinical trials to be registered on a publicly accessible database, this requirement has not changed.

    Automatic registration will be rolled out to other types of clinical trials in time.

  • Why is HRA registering clinical trials?

    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 CTIMPs approved by a REC will be publicly available for the benefit of all. Using the information already collected as part of the REC review process to register CTIMPs means that we’re making it easier for researchers and sponsors to meet their transparency responsibilities.

  • Why has HRA partnered with ISRCTN Registry?

    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 (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.

  • Why don’t you use EudraCT?

    Now that the UK has left the EU, the UK national competent authority no longer has access to the EudraCT database and can’t upload details for UK trials into this database. UK CTIMPs will no longer appear in the EU clinical trials register.

  • Is automatic registration just for clinical trials of investigational medical products (CTIMPs)? Will it be rolled out to other clinical trials?

    Automatic registration will start on 1 January 2022 for CTIMPs submitted for combined review via the new part of IRAS. The service will be rolled out to other types of clinical trials in time.

  • Will there be automatic registration for studies other than clinical trials?

    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.
  • Is automatic registration just for publicly funded clinical trials? What about those with commercial or charitable funding?

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

  • Do I have to pay? How is it funded?

    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.

  • I have just paid for ISRCTN registration – can I get a refund?

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

  • My trial is already registered on ISRCTN, will it be registered again?

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

  • My trial is already registered on another registry, will it still be registered on ISRCTN?

    HRA will register the clinical trial on ISRCTN, even if it is already registered on another registry.

  • If the trial is now going to be registered automatically by HRA, does this mean that a registration on Clinicaltrials.gov is no longer required

    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.

  • Many sponsors register with Clinicaltrials.gov and don't see the benefit of registering with ISRCTN Registry. Why do they need to register twice?

    The HRA will automatically register clinical trials with ISRCTN to ensure that all UK clinical trials are registered. Companies are still free to choose to register with Clinicaltrials.gov

  • For international clinical trials, do I need to register elsewhere?

    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.

  • Will the option to register for ISRCTN through the NIHR’s Central Portfolio Management System be removed?

    No. From 1 January 2022 only CTIMPs processed through combined review in the new part of IRAS 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.

  • How can I request a deferral? Will it be the same process as now?

    CTIMPs making applications through the new part of IRAS can request to defer registration and publication of the research summary on the HRA website through the new part of 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.

  • Do I need to pay ISRCTN to publish minimum dataset for deferred trials? What about when the deferral period comes to an end and the trial is registered?

    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.

  • How do I register if I am submitting a non-CTIMP?

    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

  • I don’t want my study to be registered with ISRCTN Registry, what do I do?

    The HRA will automatically register your clinical trial with ISRCTN, starting with CTIMPs, unless you request to defer registration and this is approved. Having your trial already registered on another registry, however, will not be accepted as a reason for deferring registration with ISRCTN. You can still register your trial on another registry.

  • My CTIMP has been submitted through combined review but is not registered yet, can this be automatically registered on ISRCTN?

    Automatic registration will apply to CTIMPs submitted through the new part of IRAS from 1 January 2022. The HRA will not be registering any CTIMPs submitted before this date.

  • Does this automatic registration by the HRA fulfil the condition of a REC favourable opinion?

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

  • When does registration happen? Is there anything I need to do?

    Registration will happen after the trial receives full approval. 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

  • Do I need to let the HRA, MHRA and/or NIHR CRN know once it is registered?

    No, ISRCTN will confirm registration and pass on the registration number to the HRA and NIHR CRN.

  • What data will you be sharing with ISRCTN?

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

  • Is this process compliant with GDPR?

    A data sharing agreement between HRA and ISRCTN Registry will be put 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).

  • How do I know the information you share with ISRCTN will be shared securely?

    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.

  • If I amend my IRAS application form after REC favourable opinion, does this automatically update the ISRCTN record?

    Fields in IRAS that are shared with ISRCTN Registry will be resent to ISRCTN when they are updated so that ISRCTN records can also be updated as required. The data shared with ISRCTN is listed in this table.

  • Do lay summaries need to be submitted to the ISRCTN registry by the sponsor or is this drawn from the IRAS application submission?

    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.