Definition of Clinical Trial

According to Regulation (EU) No 536/2014, a clinical trial is a clinical study that meets any of the following conditions:

a) The assignment of the trial subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice in the Member State concerned;

b) The decision to prescribe the investigational medicinal product is taken at the same time as the decision to include the trial subject in the clinical study; or

c) Diagnostic or monitoring procedures additional to normal clinical practice are applied to the trial subject.