en
Dictionary:

Clinical trial

An experimental clinical study where the study participants are allocated some type of treatment, such as a medicine or a medical device. A clinical trial must be approved by the Ethical Review Authority before it may start. For trials using medicine, authorisation from the Medical Products Agency is also required. Clinical trials 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.