ICH E3 Structure and content of clinical study reports

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/137/95
Published01/07/1996
Effective from01/07/1996
KeywordsClinical study report, synopsis, ethics, investigator, patient, study administrative structure, study design, study population, treatment, statistical plan, sample size, efficacy evaluation, safety evaluation
DescriptionThis 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.

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