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    Blinding and Masking

    Procedures that hide treatment assignment from patients, investigators, or assessors to reduce bias.

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

    Definition

    Single-, double-, and triple-blinding apply progressively to patients, investigators, and outcome assessors. Device trials often achieve only assessor-blinding due to the visible nature of devices/procedures.

    What this means in practice

    Independent core labs and blinded adjudication committees are standard mitigations for device trials where full blinding is impossible.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ICH·2ISO·1
    1. 1
      ICH E9
      Verified
      ICHich.org
    2. 2
      ICH Guidelines
      Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Verified
      ISOiso.org

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