All of our clinical research must adhere to strict rules and regulations.
These regulations and standards are designed to:
- safeguard and protect research subjects
- minimise risk
- monitor practice and performance
- sustain excellent research and good science
- ensure quality data and outcomes.
Clinical trials of medicinal products and devices
Researchers conducting clinical trials of investigational medicinal products or medical devices must ensure that they adhere to all relevant pieces of UK and international legislation to ensure the health and safety of research participants and the integrity of trial data. These include:
- the European Commission's Clinical Trials Directive (2001/20/EC)
- the Medical Devices Directive (93/42/EEC)
- Medicines for Human Use (Clinical Trials) Regulation 2004
- Good Clinical Practice
- Human Tissue Act 2004
Research in the NHS
Research involving NHS patients, staff, information or facilities must comply with the UK Policy Framework for Health and Social Care Research. It is subject to an ethical review at both local and national levels.
The NHS Health Research Authority oversees the overall structure and operation of research ethics governance across the UK. Research Ethics Committees across the UK serve specific regions and are responsible for reviewing university research projects. The Multicentre Research Ethics Committee reviews large scale multicentre clinical research projects.
Good Clinical Practice Training
All clinical researchers receive Good Clinical Practice (GCP) training to protect the rights and safety of research participants. The training is renewed every two years.
We work in partnership with the Cardiff and Vale UHB to provide GCP training for our researchers.