ICH E3 Structure and content of clinical study reports
| Current effective version |
|
| Reference number | CPMP/ICH/137/95 |
| Published | 01/07/1996 |
| Effective from | 01/07/1996 |
| Keywords | Clinical study report, synopsis, ethics, investigator, patient, study administrative structure, study design, study population, treatment, statistical plan, sample size, efficacy evaluation, safety evaluation |
| Description | 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
questions and answers
. |