DefinitionThis section has been translated automatically.
According to GCP (ICH E6), Directive 2011/20/EC and AMG § 40, a clinical study must include a continuous evaluation of risk and benefit. The clinical trial may only be conducted in humans if the foreseeable risks and disadvantages for the trial subject / test person are acceptable in comparison to the anticipated benefit from the drug.
Prof. Dr. med. Peter Altmeyer