Objectives

After passing the study module, the student:
1) understands the phases and flow of clinical drug development studies
2) identifies relevant restrictions and error sources in clinical drug studies
3) can evaluate ethical aspects of a clinical drug trial
4) knows the principles of GCP and the central legislation and regulatory guidance for clinical drug research
5) understands the tasks of different professional groups in the efficient and safe implementation of a clinical drug study
6) is able to compile a protocol for a clinical drug trial
7) understands the basics of statistical analysis applicable in clinical trials
8) can critically interpret publications on clinical drug trials.