The first textbook for study assistants/Study Nurses. This book integrates a textbook for beginners and a practical reference guide for advanced study assistants. The study assistant or Study Nurse has become a central component of a study outpatient clinic. They coordinate the operational process during a study. In addition to preparing a clinical study, they are responsible for documentation, assist with monitoring, and oversee quality guidelines during the study. This requires extensive expertise, which this textbook and practical guide compiles. From fundamentals to an integrated workshop, this book offers substantial and practical knowledge for further education and daily workflows. Overview: organization of clinical studies, laws and regulations, patient rights and safety, pharmacology.