Esra Kiziltepe Kisakesen

I got a solid idea in which who is responsible of what when conducting a clinical research considering regulatory elements both national and EU legislation of the clinical trials. I liked the motto ‘Think European, act national’ when considering starting to work as a CRA, having this motto in the pocket to ensure patients safety and compliance with the regulatory elements. This course gives a sharp background about the legislations regarding CTs in Europe and USA and taking this course allows the trainee to develop the idea that who is responsible of doing what with the documentation traceability of the clinical research in the light of ICH-GCP and CTs should be in compliance with regulatory requirements enforced by various authorities with everything must be documented to ensure transparency, traceability and data integrity.