clinical study
as defined in Regulation (EU) No 536/2014 of the European Parliament and of the Council of…, Article 2(2), point (1) (Definitions)
(1)
‘Clinical study’ means 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;