UKSI 2004 No. 1031 and UKSI 2006 No. 1928
The Medicines for Human Use (Clinical Trials) Regulations 2004 (UKSI 2004 No. 1031) and The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (UKSI 2006 No. 1928) are statutory Instruments which are probably the most important regulations that apply to clinical research in the UK and they have the force of law behind them.
However like most other Statutory Instruments they do not make easy reading. The wording and the structure of the regulations is necessarily somewhat legalistic and complex, because they need to function effectively as Statutory Instruments.
Statutory Instruments must:
- Contain clear and unambiguous definitions and statements
- Have plentiful cross referencing to other pertinent components of regulation or law operating in the same area
To help readers absorb and understand the core messages from the texts the MHRA issued an excellent 17 page summary of the 129 page UKSI 1031 when it became effective. See Further Reading and Resources.
