About Us

Clinical Research Ethics Committee, Gazi University Clinical Research Ethics Committee, Ministry of Health by April 13, 2013 date, and 28,617 in the Official Gazette published on Clinical Trials Under the Regulation, the Ministry of Health Medicines and Medical Devices Agency 4.4.2013 history and 36970 numbered article is approved by.

Our Board dated 13 April 2013 "Regulations on Clinical Trials" within the scope of clinical research with all relevant regulations in the scope of the " Non- Interventional Clinical Studies" has been configured to evaluate.

 

Regulation on Clinical Trials

Scope

ARTICLE 2 - (1) These Regulations, bioavailability and bioequivalence studies, including a license or authorization, even though the people to be done on pharmaceuticals, medical products and herbal medicinal products and non-pharmaceutical clinical research, clinical trial sites and will research the natural or legal persons covers.

(2) Retrospective studies are beyond the scope of this Regulation.

 

Definitions

ARTICLE 4 -

Non-drug clinical research : Pharmaceutical, biological and medicinal products and medical devices and cosmetic products that people outside will be performed on a new surgical methods research, stem cell transplantation research, tissue transplantation research or organ transplant research covers.

Observational drug operation : Drug license in Turkey receives indications, posology and application forms, the Ministry of the current diagnostic and treatment guidelines in accordance with the ongoing treatment in patients with spontaneous prescribed medication data collected in epidemiological studies covers.