DefinitionInNationalLaw object

Legal definition exists in the German Medicinal Product Act §4 for clinical studies with drugs: (23) A clinical trial on human beings is any investigation on human subjects intended to investigate or verify the clinical or pharmacological effects of medicinal products, or to identify side-effects or to study the absorption, distribution, metabolisation or excretion, with the aim of ascertaining the safety or efficacy of the medicinal product. Sentence 1 does not apply to non-interventional trials. A non-interventional trial is a study, in the context of which findings resulting from persons' treatment with medicinal products are analyzed using epidemiological methods; the treatment, including the diagnosis and monitoring, shall not follow a predetermined trial protocol but shall result exclusively from current medical practice; in so far as a medicinal product requiring a marketing authorization or a medicinal product requiring an authorization pursuant to Section 21a sub-section 1 is concerned, this shall be conducted, moreover, according to the specifications regarding its use contained in the marketing authorization or authorization. Further definitions exist in other documents but are not legally binding.

Quasi-experimental long term trial, which evaluates the effects on the health in a certain population (e.g. effectiveness of a preventive measure) - through change (or the elimination) of apparently pathogenetic factors (1 Pschyrembel, 257. Edition)