What is a UTN?
Clinical trials usually now involve participants from several agencies and institutions, and often more than one country. Most countries have a requirement for the clinical trials research to be registered prior to commencing the study or within a specified time frame from approval. Single trials could be included on more than one registry and in multiple registry databases. The information included on each registry database may be different or more up to date than another. Practice in Canada was the latter with a 30 days requirement to register the trial from the time of the No Objection Letter (NOL) with no specific requirement for a specific database. Health Canada has an approval database.
The International Clinical Trial Registry Platform (ICTRP) was formed by the World Health Organization (WHO), with the endorsement of its member countries, to identify a trial regardless of multiple registration records. The new international system involves three things:
- Universal Trial Number (UTN),
- WHO registry criteria
- ICTRP search portal to link or bridge records from databases
New registries will include space for a UTN, and older registries are being adapted to include the UTN which is attached to the trial as early as protocol development. Some trials that never are implemented will still have a UTN. Registries with no space will include the UTN in the secondary information section. Each trial should only have one UTN. It will be the sponsor or delegated coordinating centre who should register the trial for its UTN.
The UTN may not be the trial registration number. Each trial may have several pieces of identification just like a human with multiple forms of identification: a drivers licence, health insurance number, social insurance number etc. The UTN will be more like a passport that will link the trial to all registries and will provide consistent metrics.
The UTN is not yet mandatory, but many registries are now moving towards that.
Detailed information on the new UTN can be found at https://www.who.int/ictrp/unambiguous_identification/utn_faq/en/#field
- For more information, please contact Jean Smart.