ISRCTN registration provides the unique identification number necessary for the future publication of clinical trials and other studies. You could qualify for free ISRCTN registration from the Department of Health and Social Care (DHSC) if your non-commercial study is included on the NIHR CRN Portfolio.
Research transparency is important in building trust and accountability. Ensuring clear and accessible information about studies is available for all participants, patients and the public, encourages participation and engagement in research. It also supports the sharing of research results, avoids duplication of effort for researchers, and helps foster greater understanding of the role that research plays in improving health and social care services.
The NIHR has a policy on clinical trial registration and disclosure of results. This policy was developed in response to NIHR signing the WHO Joint Statement on public disclosure of results from clinical trials. The policy applies to all Clinical Trials where all of the research costs (as defined by AcoRD) are funded by the NIHR. The spirit of this policy also applies to other NIHR research and all studies should work towards following the principles within it.
Please note: From 1 January 2022, all Clinical Trials of Medicinal Products (CTIMPs) and combined trials of an investigational medicinal product and a medical device (IMP/Device trials) will be automatically registered by the Health Research Authority (HRA). See the HRA website for further information.
Which studies are able to register using CPMS?
All non-commercial studies, eligible for Clinical Research Network (CRN) support, and which have a study identifier, are able to register for an ISRCTN using the Central Portfolio Management System (CPMS).
How do I register my study?
Once your CPMS study record is ‘Live’, log in to the system and select 'Edit' on your study record.
On the ‘Identifier & Status’ tab, click ‘Apply for ISRCTN Number’ to go to the ‘ISRCTN Registration’ page. You will then be required to complete additional data fields before selecting ‘Apply for ISRCTN’ at the bottom of the page.
Which studies are eligible for free ISRCTN registration?
To qualify for free registration, studies must meet the following criteria:
- The study must be non-commercial and eligible for inclusion on the NIHR CRN Portfolio;
- The study design must contain an interventional component; it is not solely an observational study.
- At the point of applying, the CPMS study status must be ‘In set-up’ or ‘Open’ or ‘Closed – in follow-up’. An application cannot be made until eligibility has been confirmed.
- The study must be taking place in England. This includes Devolved Administration-led studies with sites in England.
- The study must not already be registered with the ISRCTN registry or ClinicalTrials.gov.
Can I register my study if it is NOT eligible for free registration?
Yes, non-commercial observational studies and studies running in the devolved administrations (with no sites in England) can still register for ISRCTN via CPMS. If you choose to register we will flag this to ISRCTN registry who will invoice the study sponsor for the full registration fee. Commercial companies wishing to apply, should contact ISRCTN directly.
Up-to-date details on the ISRCTN registration fee are available here.
How will payment for registration to ISRCTN be arranged?
- If your study qualifies, the Department of Health and Social Care (DHSC) will fund the ISRCTN registration of your study. The ISRCTN registry will then contact you to provide you with the ISRCTN for your study.
- If your study does not qualify for ISRCTN registration funded by the DHSC, the ISRCTN registry will invoice your study sponsor.
For the current cost of trial registration, please visit the ISRCTN website.
Do I need to apply directly to ISRCTN registry for ISRCTN registration?
From 1 January 2022, all CTIMPs and combined IMP/Device trials will be automatically registered by HRA, and do not need to apply directly to ISRCTN or via CPMS.
For all other study types, if you apply for an ISRCTN using CPMS then the details of your study will be automatically forwarded to the ISRCTN registry and the ISRCTN editorial team will contact you in due course. Please do not apply directly to the ISRCTN registry if you are registering for an ISRCTN via CPMS. Any duplicate applications that occur will be managed by the ISRCTN registry.
What if my study has an ISRCTN reference or is registered with another register (i.e. ClinicalTrials.gov)?
If your study already has an ISRCTN or ClinicalTrials.gov reference, you do not need to register for an ISRCTN using CPMS. Instead, you should advise the NIHR Clinical Research Network of your existing ISRCTN or ClinicalTrials.gov reference number.
How will I find out about the ISRCTN allocated to my study?
Following your ISRCTN registration via CPMS, the ISRCTN registry will contact the study coordinator (as recorded in CPMS) for your study with details of the ISRCTN. The NIHR Clinical Research Network will also be informed and the allocated ISRCTN will automatically be added to the study record in CPMS.
What do I do if the ISRCTN information I submitted through CPMS needs to be updated?
It is the responsibility of the study coordinator or the chief investigator to ensure that the relevant study information held in CPMS is current and correct by keeping the study record up to date. Please note, any updates made to this information in CPMS will not be forwarded to the ISRCTN registry once the ISRCTN has been issued.
If the HRA is going to automatically register studies, will the option to register for ISRCTN through the NIHR’s Central Portfolio Management System be removed?
No. From 1 January 2022 only CTIMPs and combined IMP/device trials processed through the HRA/MHRA’s combined review process will be automatically registered. ISRCTN registration through CPMS will continue to be available and should be used by all other study types.