Clinical trials unit

Clinical trials units (CTU) are specialised

, surgical trials, and health services research. Some specialise in one disease type, whereas others are generic units. Some CTUs focus on specific phases and types of clinical trials; others conduct all phases and types of trial.

United Kingdom

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.^[1]

Provisional CTUs tend to be newer and evolving CTUs and have not yet built a track record but have relevant expertise and experience that is worth building on. Evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration in the future.^[1]

Medicinal clinical trials are only a subset of all trials undertaken by Registered Clinical Trials Units in the academic sector. Such Units may also specialise in surgical trials, therapy trials and other complex interventions such as educational interventions.

In the

Notes

References

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

. All relevant terms must be followed.

External links

• Clinical Trials at
  Curlie