1. Is a drug administered to more than one patient in conditions other than those authorised?
2. Is a drug administered to healthy volunteers in order to assess its kinetics, activity on a biological marker, effectiveness or safeness?
3. Are there two or more concurring control groups and are treatments assigned to the different groups randomly?
If you have answered “YES” to any of the above questions, your study is a clinical trial with drugs and must be regulated in accordance with the specific standard.