Protocol Deviations vs Amendments: Clarifying the Boundary
Protocol Deviations vs Amendments: Clarifying the Boundary Clarifying the Boundary Between Protocol Deviations and Amendments Why It Matters: Deviation or Amendment? Protocol deviations and amendments are two common mechanisms by which a clinical trial departs from its original plan. However, they differ significantly in cause, handling, and regulatory implications. Misclassifying a deviation as an amendment—or…
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