• information on the sponsor, investigators, and participating study sites with contact data
• scientific background of the disease, investigational medical products, etc.
• necessity and goal of the clinical trial
• statistical parameters (number of cases, target figures, hypotheses, …)
• study design
• treatment plan incl. investigational methods, laboratory parameters, etc.
• inclusion and exclusion criteria for potential study participants
• termination criteria
• data collection, documentation and evaluation
• registration, documentation, and registration of AEs and SAEs

The trial protocol must be approved by the corresponding higher federal authority and given a favourable opinion by the ethics committee before starting a clinical trial. Essential changes to the trial protocol that occur after the start of the clinical trial, known as substantial amendments, must be approved by the aforementioned institutions.