DefinitionInNationalLaw object

Definition in national law

No specific definition of an observational study in respect to a nutritional epidemiology exists, but within the EC guidelines a definition of an ‘observational study’ is

A study where any 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 2001/20/EC).