ICH E6(R3)
In Good Clinical Practice & ethics
Also known as: E6 R3, revised GCP
ICH E6(R3) is the modernised revision of the GCP guideline, reorganized around a set of overarching principles plus annexes. It puts more weight on proportionate, risk-based thinking, on data governance across the whole data lifecycle, and on designs that use decentralised elements and real-world data sources. Regulators are adopting it region by region, so the exact date it applies depends on where you work.
Why it matters
R3 shifts the emphasis from checking every box to justifying what matters for this particular trial. Employers increasingly ask candidates whether they can explain that shift.
Common questions
- What is the main difference between ICH E6(R2) and E6(R3)?
- R2 added risk-based monitoring and quality management on top of the older structure. R3 rebuilds the guideline around principles, applies risk-proportionality throughout, and treats modern data sources and technology as normal rather than exceptional.
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Get your free roadmap →Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.