Good Clinical Principles (GCP) Standards in Conduct of Clinical Trials in Georgia

Nikoloz Gongadze, Levan Shalamberidze, Zaza Chapichadze

Background: This article presents the principles for carrying out clinical trials of drugs in Georgia in compliance with the international standards and the Declaration of Helsinki of the World Medical Association and WHO Good Clinical Practice standards. Methods: The review of 7 international multi-center clinical trials in Georgia and the new legislation of Georgia and European guidelines in this field are presented in the article. The ways of adaptation and implementation of this rules in Georgian practice are discussed. Ethical, regulatory, and other aspects required by international law are considered from the point of view of Georgian Drug and Pharmacy Law. Results: all international multi-center clinical trials conducted in Georgia confirms to the international standards and the Declaration of Helsinki of the World Medical Association and WHO Good Clinical Practice standards.

Keywords:   GCP, Good Clinical Practice, Ethical Committee, informed consent, clinical trials