Clinical Trial Practice and Management
The objective of this program is to impart broad-based knowledge about the theoretical aspects and practical management of clinical trials. It covers the ethical and regulatory background of clinical research, all relevant aspects of the planning and conduct of trials with drugs and medical devices as well as quality control and project management issues. Special attention will be paid to challenges arising from international multicenter trials. The program is geared primarily toward non-medical study staff from academic or pharmaceutical clinical research working under various job descriptions such as study coordinators, clinical monitors, study nurses or clinical research assistants who wish to attain a management position.
Students are trained to be specialists who are in a position to expertly manage studies using standard quality- and project-management concepts ranging from study planning to data preparation. Personal and social skills will be refined with the objective of optimally utilizing one’s own resources in an interdisciplinary and multinational context. In addition to gaining a university certificate (“Diploma of Advanced Studies”) this course offers those who complete the program access to a professional network and a newly developing professional group of specifically trained study specialists.
This course is organised by the CTU Clinical Trial Unit, University Hospital Basel