According to GCP, the sponsor of a clinical trial is responsible for establishing and maintaining systems for quality assurance and quality control. A clinical quality management system (QMS) ensures compliance with ethical, legal and regulatory requirements, establishes uniform quality standards from the planning and execution to the completion of clinical trials and continuously monitors compliance.

The quality management of the ZKS Ulm provides the operational departments of the ZKS Ulm (e.g. project management/regulatory affairs, monitoring, data management, (pharmaco-) vigilance) with a QMS.

The ZKS Ulm is also responsible for setting up and continuously developing a central QMS for self-initiated clinical trials (IITs) at Ulm University Hospital, for which Ulm University Hospital assumes sponsor responsibility (sponsor QM).