This ICH GCP Guideline is composed of Principles and Annexes that expand on the principles, with specific details for different types of clinical trials. The principles are intended to apply across clinical trial types and settings and to remain relevant as technological and methodological advances occur. The principles outlined in this guideline may be satisfied using differing approaches and should be applied to fit the intended purpose of the clinical trial.
Annex 1, including its Appendices, is intended to provide information on how the Principles can be appropriately applied to clinical trials. Additional annexes may be developed to respond to the needs of interested parties and to address emerging innovations in trial design and conduct. This guideline should be read in conjunction with other ICH guidelines relevant to the design and conduct of clinical trials, including multiregional trials.