An attractive location for your clinical study
The Principal Investigator submits an application for approval to the Helsinki Committee (IRB) at their institution. This is the primary ethical review body for all clinical trials.
Trials defined as "special" under regulations are conveyed for final approval to the Director of the Hospital where the study is conducted.
Non-special trials require additional approval from the Director General of the Ministry of Health, via the Clinical Trials Department in the Pharmaceutical Administration.