Sort Failure Modes by FMEA Priority
Sort clinical trial failure modes into FMEA response categories based on severity, occurrence, and detectability.
Sort each decentralized-visit failure mode by the response its FMEA profile suggests. Prevention control High severity and should be stopped before it can happen. Early detection control Important failure that may happen, so catch it before impact grows. Routine monitoring Visible or moderate issue handled by normal review. Watchlist / park Low current priority with a trigger for reassessment. Home nurse may miss pregnancy test before dosing; impact is subject-safety critical and hard to fix afterward. prevent High severity and late detectability call for pre-dose checklist hard stop. Courier may deliver wrong lab kit type; site can detect at receipt…
Sign up free — one personalized lesson every day, matched to your role and goals.
Already have an account? Sign in