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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 CELEX: 02014R0536-20221205 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. |