Practice & Standards International Council for Harmonisation (ICH) · January 6, 2025 · International (ICH regions)
ICH adopts E6(R3), a full rewrite of the Good Clinical Practice guideline (external link to International Council for Harmonisation (ICH))
ICH adopted E6(R3), the revised Good Clinical Practice guideline, in January 2025, superseding E6(R2). The revision restructures GCP into overarching principles plus Annex 1 for interventional trials, and gives data governance a dedicated section covering the responsibilities of sponsors and investigators across the data life cycle — computerized systems, traceability, access, and protection of blinding. The guideline is written to be media-neutral, and it treats quality-by-design and risk-proportionate approaches as organizing expectations rather than options. Regulators in each ICH region implement the guideline on their own timelines.
Why it matters
This is the first top-to-bottom rewrite of GCP since 1996, and it speaks the language of data management directly: data governance and life-cycle data integrity are now explicit GCP, not implications drawn from it. Data managers should map current SOPs — especially around computerized systems, audit trail review, and data corrections — against Annex 1's data governance section, and track when each regulator they answer to adopts E6(R3) into local requirements.
International standards body guideline · Topics: Good Clinical Practice, ICH E6(R3), data governance, quality by design · Checked September 1, 2026 · Read the original at International Council for Harmonisation (ICH) (external link)