From: www.ich.org
The ICH E8 (R1) DRAFT reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.
The modernisation of ICH E8 is the first step towards the GCP Renovation initiated in 2017, and is expected in order to incorporate the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials.
The revision would propose to:
1. 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;
2. address a broader range of trial designs and data sources; and
3. provide an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies.
Access the document E8 (R1) Draft Guideline.
Comments must be sent to ICH Secretariat to step2comments@ich.org according to E8(R2) accordeon for each Regulatory region's commenting period.
