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    Good Clinical Practice

    International quality standard for designing and conducting clinical trials.

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

    Definition

    GCP is an international ethical and scientific quality standard for clinical investigations. ICH E6(R3) and ISO 14155 (devices) define expectations for protocol, monitoring, data integrity, and subject protection.

    What this means in practice

    GCP compliance is verified during sponsor and investigator-site inspections (FDA BIMO, EMA GCP). Findings can invalidate trial data.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ICH·1AHRMM·1AdvaMed·1
    1. 1
      ICH E6(R3)
      Verified
      ICHich.org
    2. 2
      AHRMM - Healthcare Supply Chain
      Verified
      AHRMMahrmm.org
    3. 3
      AdvaMed Code of Ethics
      Verified
      AdvaMedadvamed.org

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