ICH E8 General considerations for clinical trials

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/ICH/5746/03
Published01/03/1998
Effective from01/03/1998
KeywordsClinical investigation, clinical development, clinical trials
DescriptionThis document addresses the general considerations for clinical trials and the process of clinical development of pharmaceuticals for human use. It aims to provide a unified principles and practices for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

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