Safety Management Plan & Unblinding Procedures: A Regulator-Ready Operating Blueprint (2025)
Safety Management Plan & Unblinding Procedures: A Regulator-Ready Operating Blueprint (2025) Safety Management Plan and Unblinding Procedures—Protecting Participants Without Compromising the Blind Purpose, Ethical Frame, and Global Anchors for Safety & Code Breaking The Safety Management Plan (SMP) and the unblinding procedures are the operational core of participant protection. Together they define how adverse events…