Odense den 11.-13. marts 2019

PhD Course: GCP and Investigator-initiated clinical trials


This course is intended for academic researchers who are about to conduct at clinical trial with a medicinal product or a medical device.

Focus will be on the practical aspects of how to comply with national regulations for these types of trials. The principles of Good Clinical Practice (GCP) and all requirements regarding the protocol of the project, the application, current reporting and quality assurance will be explained.

During the course examples will focus mainly on the present conditions for researchers at the University of Southern Denmark and generally in the Region of Southern Denmark.