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

SECTION 1GOOD CLINICAL PRACTICE

Article 2

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.