Expert design, conduct and analysis of clinical trials and other well designed studies is vital to ensure high quality, successful and timely trial conduct and to meet regulatory and governance requirements. High quality trials management expertise is therefore key to the development of research activity within the UKCRC and the clinical research networks. It is also crucial that there is sufficient national capacity to develop and manage the increasing numbers of trials generated from the UKCRC and clinical research networks' activities.

To help achieve this, a Registration Process has been established for CTUs responsible for coordinating multi-centre clinical trials and other well-designed studies. The UKCRC Registration process is designed to help improve the quality and quantity of available expertise to carry out clinical trials in the UK.

In 2007, applications from CTUs seeking UKCRC Registration were assessed by an International Review Committee, chaired by Professor Adrian Grant, and in November 2007, 40 CTUs from across the UK were awarded UKCRC Registration. A second call was made in 2009 and applications were assessed by the International Review Committee, chaired by Eleanor McFadden. In December 2009, ten CTUs from across the UK were awarded UKCRC Registration. There are two levels of Registration: Full and Provisional. Provisional Registration was awarded to CTUs that are working towards possessing the expertise to enable Full Registration status.

Full Registration
In order to obtain Full Registration status, CTUs were required to demonstrate:

• A track record and experience of coordinating multi-centre randomised controlled trials or other well-designed studies
• Presence of a core team of expert staff to develop studies
• Presence of robust quality assurance systems and processes to meet appropriate regulations and legislation (e.g. the principles of Good Clinical Practice, the NHS Research Governance Framework, the Data Protection Act and the UK regulations that implement the EU Directive for Clinical Trials)
• Evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio, including core funding or evidence of a rolling programme of grants, with evidence of commitment from the host institution.

CTUs which were already accredited by the National Cancer Research Institute (NCRI) for the conduct of multi-centre cancer clinical trials automatically became eligible for Full UKCRC Registration provided that they agreed to commit to the UKCRC Registered Trials Units best practice principles.

Provisional Registration
It was recognised that some new and evolving CTUs may be developing relevant expertise and experience that is worth building on, but that these CTUs may not yet meet all of the criteria for Full Registration status. Therefore, evaluation criteria for Provisional Registration were developed which recognised CTUs that are clearly working towards possessing sufficient experience and expertise to obtain Full Registration. CTUs were granted Provisional Registration only if they were able to demonstrate evidence of the competencies for Provisional Registration.

Further information about the key competencies and evaluation criteria used for Full and Provisional Registration can be found here.