Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance) (c. 28)

CHAPTER 2 U.K. GOOD CLINICAL PRACTICE FOR THE DESIGN, CONDUCT, RECORDING AND REPORTING OF CLINICAL TRIALS

SECTION 1 U.K. GOOD CLINICAL PRACTICE

Article 2 U.K.

1. The rights, safety and well being of the trial subjects shall prevail over the interests of science and society.

2. Each individual involved in conducting a trial shall be qualified by education, training, and experience to perform his tasks.

3. Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects.

4. The necessary procedures to secure the quality of every aspect of the trials shall be complied with.