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    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. E6(R3), adopted by ICH in January 2025, reorganizes the guideline around principles, quality by design and risk-proportionate approaches, and is written to fit decentralized elements and digital data sources. ICH E6 is written for drug trials; device investigations follow ISO 14155, which aligns closely with GCP principles. FDA and the EMA both reference ICH E6 in their guidance.
    What the regulation says
    ICH E6 Good Clinical Practice provides a unified standard for clinical trials, ensuring the protection of human subjects and the integrity of clinical data. While initially focused on drug trials, its principles are widely referenced and adapted for medical device clinical investigations, often in conjunction with ISO 14155, by regulatory bodies such as the FDA and those in the European Union.

    What this means in practice

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

    Examples

    • A medical device company conducting a pre-market clinical investigation for a novel implantable device implements an ICH E6 compliant quality management system for trial oversight.
    • A clinical research organization performing a post-market clinical follow-up study for an approved MedTech product ensures that informed consent processes align with ICH E6 guidelines.
    • During an FDA audit of a medical device clinical trial, the sponsor is asked to demonstrate adherence to ICH E6 principles for data management and record-keeping.
    Common pitfalls
    • •Failing to recognize that ICH E6, while primarilyfor drug trials, is a foundational document influencing medical device clinical investigation expectations.
    • •Assuming that adherence to ICH E6 alone is sufficient for medical device trials without considering device-specific standards like ISO 14155.
    • •Overlooking the criticality of a robust quality management system, as outlined in ICH E6, for all clinical trial activities.

    Frequently asked questions

    While ICH E6 was developed for pharmaceutical clinical trials, its core principles regarding ethics, data integrity, and subject protection are frequently applied or adapted to medical device clinical investigations, often complementing device-specific standards such as ISO 14155.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
    Link health: 3 verified· last checked 2026-06-20
    ICH·2ISO·1
    1. 1
      ICH E6(R3)
      Tier 2 Verified
      ICHich.org
    2. 2
      ICH Guidelines
      Tier 2 Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Tier 1 Verified
      ISOiso.org

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