Trial protocol / study protocol Prüfplan
The trial protocol, also known as the study protocol or the test protocol, is the basis of every clinical trial. In includes detailed information on the conduct of the study. ICH-GCP section 6 lists the obligatory contents of a trial protocol. Some of the most essential elements are listed here:
  • 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.

Deutsche Erklärung