Useful websites

Modelled on the Clinical Trials Tool Kit, this resource provides practical advice on implementing statutory and good practice standards for research involving personal information and human tissue samples. It considers the requirements of relevant primary legislation (including involving adults who cannot give consent for themselves and children) and covers the differences across the UK. 

If you would like to discuss the Tool Kit or any other Regulatory Support Centre initiative, please contact Rachel Smith (r.smith@hrsu.mrc.ac.uk).

Developed by the Medical Research Council and the Department of Health, this website uses route maps to navigate through the current regulations. The website has been developed for clinical trialists and R&D managers working in the academic sector primarily, but will also be of use to other health professionals.

NRES is a national patient safety agency within the UK, responsible for coordinating ethics approval of clinical trials.

The Eudravigilance website contains information about European regulations, directives and guidance documents.

The European Commission have updated (April 2006) their question and answer clinical trial documents and this is a useful source concerning their interpretation of the definition of a clinical trial.

The EMEA is a de-centralised body of the European Union with headquarters in the UK. Its main responsibility is protection and promotion of public and animal health. The Clinical Trials Application is processed by the EMEA and then submitted to the MHRA for review prior to any approvals being granted.

The MHRA is a government agency within the UK with responsibility for ensuring that medicines and medical devices are safe and they work. The site contains information on forthcoming conferences, frequently asked questions and recent news.

The Medical Research Council (MRC) is a national organisation funded to promote research into all areas of medical and related science, with the aim of improving the health and quality of life of the UK public.

The National RDSU Network is a group of professional research support units funded by the National Coordinating Centre for Research Capacity Development (part of NHS R&D) in order to support high quality and multi-disciplinary health and social care research.

The NHS R&D Forum was set up in 2002 with the aim of facilitating and encouraging the sharing of best practice through the development of a communications network. The Forum organises events such as conferences, seminars and workshops to provide an interface between the Department of Health and those engaged in managing and organising research in health and social care organisations.

The UKCRC R&G Advice Service provides support for local advice providers and a route for handling more complex queries such as those involving more than one regulatory issue. It also provides access to a range of web-based resources including tool kits and a new Q&A site.