ICH E8(R1) draft Guideline on General Considerations For Clinical Studies: presentation available on the ICH website

12 juin 2019


This revision of the ICH E8 Guideline incorporates the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials, including to: identify a basic set of critical-to-quality factors that can be adapted to different types of trials to support the meaningfulness and reliability of trial results and to protect human subjects; address a broader range of trial designs and data sources; and provide an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies. The modernisation of ICH E8 is the first step towards the GCP Renovation initiated in 2017.


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