This guideline applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities. The Principles of GCP in this guideline may also be applicable to other interventional clinical trials of investigational products1 that are not intended to support marketing authorisation applications in accordance with local requirements.
The Annexes provide the basis for the appropriate interpretation and application of the principles and should therefore be appropriately considered; however, various approaches to the provisions in the Annexes may be considered provided they are justified and achieve the intended purpose of the application of the principles.
This guideline encourages a risk-based and proportionate approach to the conduct of a clinical trial.