A guidance document entitled “Structure and Content of Clinical Study Reports,” developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Expert Working Group. They were formalised in 1995 “to assist sponsors in the development of a report that is complete, free from ambiguity, well organised and easy [for regulators] to review.” Most clinical study reports follow the general structure laid out in the E3 guidelines, which have not been updated since 1995.
ICH E3 guideline
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