12 June 2019

The ICH E8(R1) draft Guideline on General Considerations For Clinical Studies reached Step 2b of the ICH Process in May 2019 and now enters the consultation period. Additionally, a Step 2 Informational Presentation has also been developed by the Expert Working Group.

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.

Further information can be found on the E8(R1) page, including the Step 2 Informational Presentation for download.