This online course offers a practical introduction to quality management (QM) in clinical research. In five clearly structured chapters, participants learn about the key elements of a quality management system (QMS) and understand the role a QMS plays in ensuring the quality, safety and integrity of clinical trials. In addition, the course shows how a QMS can be set up with manageable effort, who is responsible for its implementation, and how the QMS solution ‘Orca’ from the Department of Clinical Research (DKF) Basel can help establish a quality management system that meets the regulatory requirements and framework conditions of academic research in Switzerland.
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