Non-interventional observational studies

Observational research is research in which one describes or analyze actual events, wherein observation of a given factor or intervention does not depend on scientific research protocols. Observational research includes analytical research such as cohort, case-control, cross-sectional, and descriptive research (case reports or case series). This type of research does not require approval from a bioethics committee.

According to Art. 37al Dir. 1 Pharmaceutical Law observational research do not contain elements of “intervention”.

This requires

  • Medicinal products are used in the indicated way after initial authorization and marketing
  • Assigning the patient to a cohort, which uses the specific method of treatment and is not followed by a trial protocol, but depends on established practices, and the decision to prescribe the medication is clearly separated from the decision to include the patient in the research
  • Patients are not subject to any additional diagnostic or monitoring procedures, and analysis of data collected is used for epidemiological purposes