About the CTU Registration Process
In 2007, a nationally recognised registration process was introduced for UK-based Clinical Trials Units (CTUs). This process was open to all units responsible for leading the design, central or national coordination, and overall analysis of high-quality multicentre trials and other robust studies. Registration has become a recognised marker or excellence within the Clinical Trials Community in the UK and Internationally.
Purpose and Ongoing Development
The registration process was established to strengthen both the quality and availability of expertise supporting clinical trials in the UK.
To ensure it remains relevant and effective, the criteria for both provisional and full registration are reviewed on a periodic basis that is proportional to full membership renewal frequency. These reviews help to maintain high standards of quality and competence, while also identifying opportunities to adapt to emerging challenges and developments in the research landscape.
Overall, stakeholders (including CTU Directors, MHRA and PPI&E contributors) supported the current approach, with no major structural changes recommended. Several thoughtful refinements were agreed.
These included strengthening current PPI&E criteria and introducing an Equality, Diversity and Inclusion element, as well as updating language in the Information Systems and Statistics sections to reflect current practice.
This review has reaffirmed the strength of the basis of the existing registration framework and highlighted its continued value. By maintaining a clear marker of excellence across all stages of non‑commercial trials, the CTU Network continues to play a vital role in supporting high‑quality research and safeguarding the UK’s global reputation for clinical trials excellence.
You can read more about the recent comprehensive criteria review process here.
Application Resources
Below you will find the latest registration criteria, application guidance, and supporting materials to assist you in preparing your submission. Please contact regctus@leeds.ac.uk with any queries.
Applying for Registration
The next registration call will open in Spring 2027.
Any unit that considers it meets the published criteria is encouraged to apply.
