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

Table of contents

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 PDF icon questions and answers.

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


How useful was this page?

Add your rating
7 ratings
1 rating
1 rating
1 rating