EU Clinical Trials Regulation (CTR 536/2014)
CTR - General Provisions (Ch I)

EU Clinical Trials Regulation (CTR 536/2014) CTR-Art.3: General principle (Article 3)

Article 3 sets the overarching ethical and scientific principle: a clinical trial may be conducted only if the rights, safety, dignity and well-being of subjects are protected and prevail over all other interests, AND the trial is designed to generate reliable and robust data. This principle underpins every operational article of the CTR.

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