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    I.S. EN ISO 14155:2020

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

    Available format(s):  Hardcopy, PDF

    Superseded date:  14-12-2020

    Language(s):  English

    Published date:  07-09-2020

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Summary of good clinical practice (GCP) principles
    5 Ethical considerations
    6 Clinical investigation planning
    7 Clinical investigation conduct
    8 Suspension, termination, and close-out of the clinical investigation
    9 Responsibilities of the sponsor
    10 Responsibilities of the principal investigator
    Annex A (normative) Clinical investigation plan (CIP)
    Annex B (normative) Investigator's brochure (IB)
    Annex C (informative) Case report forms (CRFs)
    Annex D (normative) Clinical investigation report
    Annex E (informative) Essential clinical investigation documents
    Annex F (informative) Adverse event categorization
    Annex G (informative) EC responsibilities
    Annex H (informative) Application of ISO 14971 to clinical investigations
    Annex I (informative) Clinical development stages
    Annex J (informative) Clinical investigation audits
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

    General Product Information - (Show below) - (Hide below)

    Committee TC 194
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By
    Supersedes
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