ISRCTN

ISRCTN is a publicly accessible clinical trial registry that accepts all research studies; both prospective and retrospective registrations are accepted. It is officially recognised by the World Health Organisation (WHO) and the International Committee of Medical Journal Editors (ICMJE) as a primary clinical trials registry.

On 20th October 2021, the Health Research Authority (HRA) announced its partnership with ISRCTN, a World Health Organisation (WHO) recognised UK registry. This partnership will be fulfilling one of the commitments pledged in the HRA’s Make it Public Strategy; that of ensuring all clinical trials approved in the UK appear on a public registry recognised by the WHO.

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 will be automatically registered on ISRCTN registry. There is no charge to sponsors or researchers for automatic registration, and this applies to both commercial and non-commercial sponsors.

The HRA has also prepared a Frequently Asked Questions (FAQ) page to provide more information about the automatic registration process.

Instructions for registering on ISRCTN (for non-CTIMPS):

• Please create an account at https://www.isrctn.com/ and click on “Register you study”. For help completing the application form, please follow the blue tooltips, download ISRCTN guidelines (PDF), read the definitions page, and watch instructional videos.
• Ethics approval details can be added before or after the study is registered.
• ISRCTN is required under the WHO standards for trial registration to obtain written third-party confirmation that a trial exists. Acceptable evidence includes letters from ethics committees, funding agencies or government regulatory authorities. We will record that this information has been provided and store the document, but the evidence will not be publicly displayed. Please send written third-party confirmation as an attachment.
• Researchers are encouraged to provide their study protocols, statistical analysis plans and participant information sheets and to add links to publications and datasets.