Beyond Compliance: Preparing Investigator Sites for ICH E6(R3)

About this session

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

Speakers

• KH

  Karen Harvey

  Sr Director · AQC

  Speaker

• MW

  Michelle Webb

  VP · WCG

  Speaker