The Clinical Trials Tool Kit
The Clinical Trials Tool Kit is a one-stop online information resource for researchers carrying out UK publicly funded clinical trials, launched in 2004 by the MRC and the Department of Health. The site is designed to help trialists to understand the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations, which implement the EU Clinical Trials Directive (2001) in the UK. Although the tool kit was developed for trials testing medicines, much of the guidance it contains is relevant to other types of trials.
How the Tool Kit works
The Clinical Trials Tool Kit site uses a series of colour-coded route maps to distinguish between and legal and good practice requirements, and to indicate which aspects of these are relevant to clinical research in general. It includes an overview of changes to trial practices after introduction of the regulations, along with more detailed information available at ‘stations’ along the route.
There is also useful practical guidance on how requirements can be implemented, including sample trial scenarios and ways of achieving the risk-based approach to trial management and monitoring endorsed by the MHRA.
The site users
Although developed primarily for clinical trialists and R&D managers working in the academic sector, the site is also of use to other health professionals, such as pharmacists or those involved in other types of clinical research. It now has more than 5,000 regular users, both from the UK and countries throughout the world.
Contact: Dr Sarah Dickson
Telephone: 020 7670 5198
Email: sarah.dickson@headoffice.mrc.ac.uk