Benefit - risk - analysis

Author:Prof. Dr. med. Peter Altmeyer

Last updated on: 29.10.2020

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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.

Authors

Last updated on: 29.10.2020

Author: Prof. Dr. med. Peter Altmeyer