Deviation Thresholds for Trial Suspension
Deviation Thresholds for Trial Suspension When Do Protocol Deviations Justify Suspending a Clinical Trial? Introduction: Deviations That Cross the Line Protocol deviations are common in clinical research, but there’s a point at which their frequency, severity, or pattern can raise serious concerns—enough to justify clinical trial suspension. Regulatory authorities, sponsors, and Institutional Review Boards (IRBs)…