ICH E3 Structure and content of clinical study reports - Scientific guideline

This document aims to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. Read together with  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline E3: Questions and answers (R1).

Keywords: Clinical study report, synopsis, ethics, investigator, patient, study administrative structure, study design, study population, treatment, statistical plan, sample size, efficacy evaluation, safety evaluation

Current effective version

ICH: E 3: Structure and content of clinical study reports - Step 5

Adopted Reference Number: CPMP/ICH/137/95 Legal effective date: 01/07/1996