DefinitionInNationalLaw object

Observational study: (Law 29/2006, of July 26): A study in which drugs/nutrients are prescribed in the usual manner, in accordance with the terms of the authorization. The assignment of a patient to a particular therapeutic strategy is not decided in advance by a trial protocol but is determined by the practice of medicine, and the decision to prescribe a particular drug will be clearly dissociated from the decision to include the patient in the study. It does not apply to patients nor intervention, whether diagnostic or monitoring, other than the usual clinical practice and epidemiological methods shall be used to analyze the data collected.