DefinitionInNationalLaw object

An observational study is a clinical study without intervention

Conditions:
i) are prescribed medications or medical devices are used in accordance with the terms specified in the marketing authorization;
ii) the inclusion of the participant in a particular therapeutic strategy is not decided in advance by a trial protocol but depends on the current practice;
iii) the decision to prescribe medicine or use a medical device is clearly separated from the decision to include the participant in the study or not;