What does E6(R3) require of trial sponsors?
The short answer
Sponsors remain accountable for trial quality even where activities are delegated. E6(R3) expects you to identify what genuinely affects participant safety and data reliability, manage those risks proportionately, and show documented oversight of every vendor and CRO acting on your behalf.
Need help getting trial-ready?
Tell us where you are and we'll handle the rest.
A reply from a person, usually within one business day.