The course is intended for academic researchers who are about to conduct a clinical trial with medicinal products or with medical devices.
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.
Intented learning outcome:
As required by the relevant Danish legislation, applying when conducting clinical trials with medical products/medical devices, participants will gain documented knowledge of the principles of GCP and an understanding of responsible conduct of research, quality assurance/control and prober data management.
Mix of lectures, discussions and exercises
Cand. Scient., Ph.d. Tanja Bidstrup
Course fee:The course is free of charge for PhD students enrolled in Universities that have joined the "Open market agreement".
For other participants there is a course fee of DKK4,277.82.