(ii)

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 · European Union

The risks and inconveniences for the subject, taking account of all of the following: the characteristics of and knowledge about the investigational medicinal products and the auxiliary medicinal products; the characteristics of the intervention compared to normal clinical practice; the safety measures, including provisions for risk minimisation measures, monitoring, safety reporting, and the safety plan; the risk to subject health posed by the medical condition for which the investigational medicinal product is being investigated;

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.