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    Data Safety Monitoring Board

    Independent committee that periodically reviews accumulating safety and (sometimes) efficacy data during a trial.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    DSMBs (also DMC) make recommendations to continue, modify, or stop a trial based on safety, futility, or overwhelming benefit. Their charter, membership, and stopping rules are pre-specified.

    What this means in practice

    Required or strongly recommended for pivotal trials with mortality endpoints, vulnerable populations, or interim analyses.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·1NIH·1ICH·1
    1. 1
      FDA DMC Guidance
      Bot-blocked
      FDAfda.gov
    2. 2
      ClinicalTrials.gov
      Verified
      NIHclinicaltrials.gov
    3. 3
      ICH Guidelines
      Verified
      ICHich.org

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