Registration of Clinical Trials Units
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 UK Clinical Research
Network (UKCRN). It is also crucial that there is sufficient
national capacity to develop and manage the increasing numbers of
trials generated from the UKCRC and UKCRN’s activities.
To help achieve this, a Registration Process
has been established for Clinical Trials Units (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.
The UKCRC-Registered CTUs will also share
expertise, systems and knowledge and act as a signpost to direct
researchers to high quality CTUs with expertise in the range of
clinical research being supported by UKCRN.
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. There
are two levels of Registration: Full and Provisional. Provisional
Registration was awarded to Units that are working towards
possessing the expertise to enable Full Registration status.
A modelling exercise will take place in 2008
to review the CTU capacity requirements in the UK. A second call
for applications is planned for May 2009.
Further information