ISRCTN registration provides the unique identification number necessary for the future publication of clinical trials and other studies. The Department of Health and Social Care (DHSC) funds ISRCTN registration for eligible NIHR CRN Portfolio studies.
Which studies are able to register?
All studies eligible for Clinical Research Network (CRN) support 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?
Log into your study on the Central Portfolio Management System and select 'Edit' to go into edit mode. Please then click ‘Apply for ISRCTN Number’ on the ‘Identifier & Status’ tab. This will take you to the ‘ISRCTN Registration’ page where you will 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?
Non-commercial studies with an interventional component included on the NIHR Clinical Research Network Portfolio qualify for ISRCTN registration funded by the DHSC in England. Please see the table below which details the criteria for free ISRCTN registration:
|Primary care design||‘Interventional’ or ‘Both’ (i.e. interventional and observational)|
|Study Status||‘In set-up’ or ‘Open’ or ‘Closed – in follow-up’|
|ISRCTN and ClinicalTrials.gov status:||Study is not already registered with the ISRCTN registry or ClinicalTrials.gov|
|NIHR CRN Portfolio study:||Non-commercial studies, ie those funded by the NIHR, central Government, NIHR non-commercial Partners, industry (funded but not sponsored), overseas Governments or overseas charities|
|Study Location||Study must be taking place in England. This includes Devolved Administration-led studies with sites in England.|
|Study Design||Study contains an interventional component, i.e. isn't solely an observational study.|
Can I register my study if it is NOT eligible for free registration?
Yes, commercial studies (industry sponsored and funded), 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.
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 (as detailed in the IRAS Form) for your study.
For the current cost of trial registration, please visit the ISRCTN website.
Do I need to apply directly to ISRCTN registry for ISRCTN registration?
No, if you apply for an ISRCTN using the Central Portfolio Management System (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.
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 apply for registration in CPMS. Instead, you should advise the NIHR Clinical Research Network of the appropriate reference number.
How will I find out about the ISRCTN allocated to my study?
Following your ISRCTN registration via CPMS, the ISRCTN registry 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 ISRCTN information held in CPMS is current and correct by updating the ISRCTN information. Please note, any updates made to this information in CPMS will not be forwarded to the ISRCTN registry following issue of the ISRCTN.
Please contact the Study Support Service helpdesk on 0113 343 4555 or email@example.com with any enquiries relating to ISRCTN registration in CPMS.