The Unique Trial Number station follows the Trial Master File station and precedes the EudraCT Number station. This process occurs in parallel with Funding Secured, Confirm Sponsor, Feasibility & Investigator Selection, and Contracts & Agreements. The Unique Trial Number is good practice and is relevant to all trials. This station is part of the ‘trial planning phase’ group of stations.
Each clinical trial must have a unique trial number and be registered on a publicly accessible database. Trial registration helps researchers fulfil research transparency and result dissemination requirements and is a condition of favourable ethics opinion (unless a deferral of registration has been granted). Many publishers, including the International Committee of Medical Journal Editors (ICMJE), require registration as a pre-condition of publication.
The MHRA has published guidance on the registration of clinical trials applicable from the 1st of January 2021. For UK only trials, established international registers such as ISRCTN registry, or ClinicalTrials.gov may be used. For clinical trials with EU/EEA sites, trials will be recorded on the EU Clinical Trials Register and a EudraCT number is obtained.
Further guidance on trial registration and research project identifiers can be found on the HRA webpages.