MedTech Terms
    The authoritative reference
    All terms
    Clinical & TrialsClinical EvidenceGCP

    ICH E6 Good Clinical Practice

    International standard for the design, conduct, and reporting of clinical trials.

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

    Definition

    ICH E6(R3) provides an internationally accepted standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials, ensuring data credibility and subject protection.

    What this means in practice

    While developed for drug trials, GCP principles are widely applied to device clinical investigations alongside ISO 14155.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    Used by

    Things that build on this term.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ICH·2ISO·1
    1. 1
      ICH E6(R3)
      Verified
      ICHich.org
    2. 2
      ICH Guidelines
      Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.