The course is intended for academic researchers who are about to conduct a clinical trial with an investigational medicinal product or a clinical trial with a medical device.
Focus will be on the practical aspects of how to comply with the 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 an 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.
Outcome: Knowledge on how to comply with current regulations and guidelines for executing clinical trials on investigational medicinal products and medical devices in Denmark.
Teaching methods: Mix of lectures, discussions and exercises
Course material: - this can be downloaded from E-learn
- BEK nr 695 af 12/06/2013 (GCP Bekendtgørelsen)
- ICH Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP)
- "Kom godt i gang med klinisk forskning"
Preparations: Exercises will be available on E-learn 2-3 weeks prior to the course
Course director: Cand. Scient., Ph.d. Tanja Bidstrup
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 DKK 3918,24