In accordance with Good Clinical Practice (GCP), the sponsor of a clinical trial with medicinal products or medical devices is obliged to record, document, assess and report adverse events. The (pharmaco-)vigilance of the ZKS ensures compliance with all legal and regulatory requirements in the context of self-initiated clinical trials (IITs) sponsored by Ulm University Hospital. A quality-assured system, the Responsible Person (RP) for Eudravigilance (central contact person for the European Medicines Agency (EMA) at Ulm University Hospital for safety issues in clinical drug trials), qualified employees and a validated pharmacovigilance database for drug trials in accordance with international requirements (GVP-, ICH E2B-compliant) are available for this purpose.