DefinitionInNationalLaw object
Definition in national law
Non interventional research is defined in Austrian law according to the European directive in AMG§2a, Paragraph 3: Applies to systematic investigation of drugs if:
1. used according to indication
2. no additional therapeutic or diagnostic interventions, no burden for patients
3. no predefined strategy of treatment, and therapeutic decision unrelated to inclusion. Typically treatment decision must precede inclusion decision. Group comparison is possible.
