ICH E6 (R3) is Live — What Actually Changes for Your Study

The ICH E6 (R3) Good Clinical Practice guideline became Step 5 on 23 July 2025. Unlike R2, R3 is written for a modern, risk-based, digitally-enabled trial ecosystem.

Top shifts you should plan around now:

• Principles-first structure — the annex now spells out how principles apply to interventional and decentralized designs.
• Proportionality — quality-management effort must match risk to participants and to reliability of results.
• Data governance — full lifecycle traceability from source through report, regardless of tool.
• Sponsor oversight of vendors — including AI and analytics providers.

Proclin's SOPs, CTMS, IWRS/RTSM and monitoring workflows were re-baselined for R3 through the summer of 2025 — including a live training we ran for OUCRU Nepal.