Clinical trials units (CTU) are specialised biomedical research units which design, centrally coordinate and analyse clinical trials and other studies.
The UKCRC evaluates CTUs in the UK and they may be given either Full or Provisional CTU registration status.
All Registered CTUs are required to provide evidence that their work is of high quality by demonstrating (1) experience of coordinating multi-centre randomised controlled trials or other well-designed studies, (2) a presence of a core team of expert staff to develop studies, (3) a presence of robust quality assurance systems and processes to meet appropriate regulations and legislation, and (4) evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio.
In 2007, a revised version of Phase I clinical trial regulations was issued following the heavily publicized multiple organ failures in several volunteers for a study of TGN1412.
[2] As of this edit, this article uses content from "Mental Health and Neurosciences Clinical Trials Unit", which is licensed in a way that permits reuse under the Creative Commons Attribution-ShareAlike 3.0 Unported License, but not under the GFDL.