Intervention study

An experimental clinical study where the study participants are allocated some type of treatment, such as a medicine or a medical device. An intervention study must be approved by the Ethical Rreview Authority before it may start. For intervention studies using medicine, authorisation from the Medical Products Agency is also required. All intervention studies involving non-CE-marked medical devices or medical devices that are CE-marked for other use than that intended in the study shall be notified to the Medical Products Agency. “Intervention study” is used synonymously with “clinical trial” on kliniskastudier.se.