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    Protocol Deviation

    Departure from the approved clinical investigation plan.

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

    Definition

    A protocol deviation is any change, divergence, or departure from the study design or procedures defined in the clinical investigation plan that does not have prior IRB/EC approval.

    What this means in practice

    Significant deviations affecting subject safety, rights, welfare, or data integrity must be reported to the IRB/EC and sponsor. Trends in deviations indicate a need for site retraining or protocol amendment.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ICH·2NIH·1
    1. 1
      ICH E6(R3) Guideline
      Verified
      ICHdatabase.ich.org
    2. 2
      ClinicalTrials.gov
      Verified
      NIHclinicaltrials.gov
    3. 3
      ICH Guidelines
      Verified
      ICHich.org

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