ICH E8 General considerations for clinical trials

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberCPMP/ICH/5746/03
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.

How helpful is this page?

Average rating:

 Based on 42 ratings

Add your rating:

See all ratings
8 ratings
8 ratings
8 ratings
8 ratings
10 ratings

Tell us more