Turkish Medicines and Medical Devices Agency Updated its Guideline on Standard Work Methods of Ethics Committees for Good Clinical Principles in Clinical Research

Turkish Medicines and Medical Devices Agency (“TITCK”) has published an updated Guideline on Standard Work Methods of Clinical Research and Bioavailability/Bio-equivalency Studies Ethics Committees, with the purpose to provide supplementary guidance to the current Declaration of Helsinki, the relevant Turkish legislation and good clinical practice principles.

The Guideline includes methods to build ethics committees and appointment of committee members, work procedures and principles, duties and authorities of ethical committees along with principles regarding applications to ethics committees and evaluation methods regarding applications.

Accordingly, in case an ethical committee breaches standard work method principle, such committee would be warned and if the breach is not remedied the breaching committee’s TİCTK approval would be cancelled preventing the committee president from being an ethics committee member for two years.

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