clinical trial
as defined in Directive 2001/20/EC of the European Parliament and of the Council of 4 April…, Article 2, point (a) (Definitions)
any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy; This includes clinical trials carried out in either one site or multiple sites, whether in one or more than one Member State;
Install the extension for EUR-Lex
Also defined in
- Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal… 32019R0006, Article 4, point (17)
a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof; - Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on… 32014R0536, Article 2(2), point (2)
a clinical study which fulfils any of the following conditions: (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned; (b) the decision to prescribe the investigational medicinal…