Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance
Article 3 General principle
A clinical trial may be conducted only if:
(a) the rights, safety, dignity and well-being of subjects are protected and prevail over all other interests; and
(b) it is designed to generate reliable and robust data.