Clinical trial regulations
Introduction
All research must be undertaken in line with all current regulations and all staff undertaking clinical trials must have current Good Clinical Practice (GCP) training certificates (less than 2 years old).
EU Clinical trials directive
The European Union Clinical Trials Directive (2001/20/EC) provides a framework setting out how clinical trials investigating safety or efficacy of a medicinal product in humans must be conducted. This includes medicinal trials with healthy volunteers and small scale or pilot studies.
The Directive aims are to:
- Provide greater protection to subjects participating in clinical trials
- Ensure quality of conduct
- Harmonise regulation and conduct of clinical trials throughout Europe
UK clinical trials regulations
Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
The Medicines for Human Use (Clinical trials) Regulations 2004
Clinical trials are regarded as Gold Standard methodology and are subject to extra regulation from other forms of research They are likely to require additional registration, and approval from the
Medicinal and Healthcare Products Regulatory Agency
(MHRA) if drugs or medical devices are involved within that trial.
Guidance on participation and set up within trials can be found at:
Clinical Trials Toolkit
MHRA The EU Clinical Trials Directive was transposed into UK Law as the Medicines for Human Use (Clinical Trials) Regulations 2004 and came into force on 1st May 2004. The UK Clinical Trials Regulations 2004 include additional controls:
- Establishment of ethics committees on a legal basis
- Each Clinical Trial must have an identified Sponsor who takes responsibility for its initiation, conduct and management
- Phase 1 pharmacology studies in healthy volunteers require authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA)
Amendments to the Regulations:
There have been various amendments to the Medicines for Human Use Clinical Trials Regulations as listed below:
The Medicines for Human Use (Clinical Trials) Amendment (No.1) Regulations SI (2006/1928)
The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations SI (2006/2984)
The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 SI (2009/1164)