LFU:online

Students acquire the knowledge on how to compose an application for a clinical trial with a medicinal product including study design, students are able to provide scientific advice for a drug application and know how to compile the documentation for the investigational medicinal product and for a marketing authorization in CTD format. Students learn how to perform data management within application processes, they have an in depth understanding of and know how to calculate quantitative parameters (e.g. cost-effectiveness parameters)

• Creation of a clinical trial protocol CIP
• Creation of an ICF
• Creation of a CRF
• Submission of the dossier to the via CTIS

seminar in which the respective documents are created in small groups with constant feedback from experts

active participation in seminar demonstrating understanding of theoretical principles and critical reasoning, delivery of required documents