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12th October 2021
The ICH E8(R1) Guideline on General considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.
Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. ICH E8(R1) provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.
This modernisation of ICH E8 is the first step towards the Renovation of Good Clinical Practice initiated in 2017. The revision incorporates the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials.