About this site
The Clinical Trials Toolkit was initially developed and launched in 2004 by the MRC and the Department of Health and Social Care to help clinical trialists and R&D managers understand the regulations and requirements for conducting trials. As the lead organisation for funding clinical trials, the NIHRhas now taken over responsibility for the Clinical Trials Toolkit.
The new current version of the site was launched in late 2012. This was developed by the NIHR, in close collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA) , Health Research Authority (HRA) , Medical Research Council (MRC) and other UK Clinical Research Collaboration (UKCRC) partners and stakeholders.
The site addresses the requirements of the current UK regulations, (which took effect in May 2004 and transposed the EU Clinical Trials Directive (2001/20/EC) into UK law). The Directive required Member States to harmonise the regulation of all trials in the EU that investigate the safety or efficacy of a medicinal product (including medicinal trials with healthy volunteers, and small scale or pilot studies). Revisions to the Clinical Trials Directive and new regulations are currently being developed by the European Commission, and this site will be updated in due course.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA), protects and promotes public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. If you remain unsure about how to ensure your trial meets the regulatory requirements, please contact the MHRA directly, using the contact details below:
Clinical Trial Helpline Tel: 020 3080 6456
The 2012 revision of the Clinical Trials Toolkit content was led by Tanya Symons (T Symons Associates Ltd), and coordinated by the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC).
The NIHR would like to thank all those who contributed both time and expertise to the revision work.
Lead updaters/ authors:
- T Symons (T Symons Associates Ltd)
- O Gupta (Mode Pharma)
- Prof L Duley, A Erven and G Bumphrey (Nottingham CTU)
- C Murphy and J Kelly (King’s CTU)
- M Bucukoglu and P Dearie – ACCORD (NHS Lothian and the University of Edinburgh)
- C Daffern (Warwick CTU)
- R Macefield and A Lane (MRC ConDuCT Hub)
- J C Hopewell (CTSU, University of Oxford)
- M Palmer and C Counsell (R&D Forum)
- M Ward, M O'Kane, J Wakelin-Smith and S Buchanan (MHRA CTU & GCP Inspectorate)
- S Bourne and colleagues (HRA).
Organisations who contributed to the review:
- The Royal Marsden NHS Foundation Trust
- The Institute of Cancer Research
- Newcastle Clinical Trials Unit
- Wales Cancer Trials Unit
- Birmingham Clinical Trials Unit
- Nottingham Clinical Trials Unit
- UCLH/Royal Free/UCL Joint Research Office
- Guy & St Thomas’ NHS Foundation Trust
- North Wales Cancer Treatment Centre
- Medicines for Children Research Network.