Data Handling & Analysis Implications of Protocol Deviations: A Regulator-Ready Operating Blueprint 2026
Data Handling & Analysis Implications of Protocol Deviations: A Regulator-Ready Operating Blueprint Managing Data and Analyses When Protocol Deviations Occur Why Protocol Deviations Are Data Problems—Not Just Process Problems Every protocol deviation leaves a footprint in the analysis. Missed windows can shift treatment effect estimates, device firmware changes can alter measurement properties, late SAE clocks…