ICH E6(R3) represents more than a revision — it reorients Good Clinical Practice around risk proportionality, quality by design, and fitness for purpose rather than uniform procedural compliance. For investigator sites, this shift carries real implications: changes to how oversight is documented, greater emphasis on data governance across the full data lifecycle, clarified investigator responsibilities including delegation and supervision, and new expectations around participant-centered trial conduct. This session translates the guideline into site-level operational practice. We'll identify which SOPs need revision, what documentation practices need to change, how site-sponsor interactions may shift, and where sites can push back on requirements not grounded in the guideline. Practical focus throughout, with time for questions.

Takeaways

• Translate ICH E6(R3) principles into concrete site SOP and documentation changes
• Clarify investigator oversight, delegation, and supervision expectations
• Apply risk-proportionate thinking to site-level quality and data governance practices