DMC/IDMC Interactions: Governing Interim Decisions, Safety Signals, and Stopping Rules with Inspection-Ready Discipline (2025)
DMC/IDMC Interactions: Governing Interim Decisions, Safety Signals, and Stopping Rules with Inspection-Ready Discipline (2025) Independent Data Monitoring That Protects Participants and Preserves Trial Integrity Purpose, Independence, and the Global Compliance Frame The Data Monitoring Committee—also called the Independent Data Monitoring Committee (DMC/IDMC) or Data Safety Monitoring Board (DSMB)—is the study’s conscience during periods when evidence…