ICH E3 Structure and content of clinical study reports
Current effective version |
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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
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