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 products is taken together with the decision to include the subject in the clinical study; or (c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects [Reg (EU) No 536/2014 Art 2(2)(2)].

See also Clinical study, Low-intervention clinical trial, Investigational medicinal product, Ongoing clinical trial, Completed clinical trial