clinical study
as defined in Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16…, Article 2(2), point (1) (Definitions)
any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; (b) to identify any adverse reactions to one or more medicinal products; or (c) to study the absorption, distribution, metabolism and excretion of one or more medicinal products; with the objective of ascertaining the safety and/or efficacy of those medicinal products