DefinitionInNationalLaw object
Definition in national law
There is no definition for “interventional studies” or “observational study”. The law defines “clinical trials and “non-interventional trials”.
“non-interventional trial": a study where the medicinal products are prescribed in the usual manner in accordance with the terms of the marketing authorization. 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.
