Regulation (EU) No 536/2014 of the European Parliament and of the CouncilShow full title

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 3General 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.