During a clinical study the main focus lies on patient safety. Therefore correct data collection and competent assessments are essential. The process of pharmacovigilance and vigilance concerning drugs and medical devices in a clinical study ensures ongoing safety monitoring of the study participants and, if applicable, uninvolved persons during the entire duration of a research project. This process includes, among other things, timely data recording and assessment, reporting of certain adverse events as well as support in the preparation of periodic safety reports.