The final ICH E6(R3) guideline reinforces where the industry has already been heading: smarter trial design, clearer accountability, and proactive risk-based oversight.
The tone is more practical, expectations are clearer, and the message is unmistakable: quality and participant protection must be planned, monitored, and documented—not inspected in after the fact.
Even when working with CROs and vendors, the sponsor retains ultimate responsibility. Oversight now means active engagement and documented decision-making, not passive reporting.
Sponsors are expected to identify Critical-to-Quality (CtQ) factors early and design processes around what truly influences safety and data reliability.
The use of terms like harm and hazard harmonizes expectations internationally and places participant well-being at the center of design and monitoring decisions.
Data review and oversight should adjust according to where risk is highest—not just on a fixed schedule.
Sponsors who already use RBQM platforms are well-positioned for E6(R3) — very little conceptual change is required, only process clarity and governance.
E6(R3) is not a dramatic reinvention — it is a maturing of expectations.
The shift is from:
A visual guide to:
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