Statutory Instruments

The European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment No. 2) Regulations 2006

The purpose of these Regulations is to implement Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use

The Regulations lay down the principles of good clinical practice and the detailed guidelines in line with those principles for the design, conduct and reporting of clinical trials on human subjects involving such products

The Regulations also lay down detailed guidelines on the documentation relating to clinical trials, archiving, qualification of inspectors and inspection procedures

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