Studies according to AMG/CTR
Within the meaning of Article 2 (2) (2) of Regulation (EU) No 536/2014, a clinical trial is
“…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."
Please also comply with our remarks regarding the subject of Data Protection (GDPR).
