Non-Interventional Study

Non-Interventional Study

EU: Clinical Trials Directive – A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data (as per Article 2(c) of Directive 2001/20/EC)

EU: Clinical Trials Regulation – ‘Non-interventional study’ means a clinical study other than a clinical trial (as per Article 2.2(5) of Regulation EU/536/2014)