Norwich Clinical Research Unit gains registration

The joint Clinical Research and Trials Unit (CRTU) run by the Norfolk and Norwich University Hospital and University of East Anglia has been awarded provisional registration.

Established in late 2005, the Norwich Clinical Research and Trials Unit includes:

• A five-bedded unit located in the Medical School's Clinical Skills resource area at the Norfolk and Norwich University Hospital.
• A main out-patient unit located in the new extension to the School of Medicine, Health Policy and Practice at the University of East Anglia.

Dr Neil Stanley, CRTU manager, said: “All those involved in the CRTU are proud that we have achieved provisional registration given that we are a relatively new unit. We will work hard in the coming months to ensure the CRTU attains full registration at the next review.”

Forty Clinical Trials Units (CTUs) across the UK have successfully gone through a new UK Clinical Research Collaboration (UKCRC) Clinical Trials Unit Registration Process. Registration is designed to help improve the quality and quantity of available expertise to carry out clinical trials in the UK.

CTUs are specialist units that bring together the experts needed to undertake a clinical trial, including clinicians, statisticians and trial managers. Running a trial is a complex process and registered CTUs have the expertise to design, coordinate and analyse multi-centre clinical trials, ensuring that they are conducted in line with appropriate standards and regulations.

The registration process was coordinated by the UK Clinical Research Network Coordinating Centre on behalf of the UKCRC. To be eligible to apply for UKCRC Registration, CTUs had to be capable of centrally coordinating multi-centre clinical trials and other well-designed studies, taking overall responsibility for the design, conduct, data management, publicity and analysis of a trial.

The CTUs were required to meet a number of key competencies, which were assessed against detailed evaluation criteria and reviewed by an international panel. These included a track record of experience in coordinating multi-centre clinical trials, presence of expert staff and robust quality assurance systems, and evidence of long term viability of capacity for trials co-ordination.