ICH E3 Structure and content of clinical study reports - Scientific guideline
HumanScientific guidelines
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
ICH: E 3: Structure and content of clinical study reports - Step 5