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    Protocol deviations are minor divergences from the study protocol that do not significantly impact data quality, participant safety, or informed consent. Protocol violations are more serious divergences that can materially reduce data quality, make the informed consent inaccurate, or impact participant safety, rights, or welfare. Examples of protocol violations include not obtaining informed consent, enrolling ineligible participants, failing to report serious adverse events, improperly unblinding a study, or using prohibited medications. The key difference is that protocol deviations do not significantly impact the study, while violations can compromise the study's integrity.

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    Protocol deviations are minor divergences from the study protocol that do not significantly impact data quality, participant safety, or informed consent. Protocol violations are more serious divergences that can materially reduce data quality, make the informed consent inaccurate, or impact participant safety, rights, or welfare. Examples of protocol violations include not obtaining informed consent, enrolling ineligible participants, failing to report serious adverse events, improperly unblinding a study, or using prohibited medications. The key difference is that protocol deviations do not significantly impact the study, while violations can compromise the study's integrity.

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    4 views3 pages

    PICR Faqtual Sep12

    Uploaded by

    Jack frimpong
    Protocol deviations are minor divergences from the study protocol that do not significantly impact data quality, participant safety, or informed consent. Protocol violations are more serious divergences that can materially reduce data quality, make the informed consent inaccurate, or impact participant safety, rights, or welfare. Examples of protocol violations include not obtaining informed consent, enrolling ineligible participants, failing to report serious adverse events, improperly unblinding a study, or using prohibited medications. The key difference is that protocol deviations do not significantly impact the study, while violations can compromise the study's integrity.

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    © All Rights Reserved
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    net/publication/232814505

    Protocol deviation and violation

    Article  in  Perspectives in Clinical Research · July 2012


    DOI: 10.4103/2229-3485.100663 · Source: PubMed

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    Arun Bhatt

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    Vol 3 / Issue 3 / Jul-Sep 2012
    Perspectives in Clinical Research ● Volume 3 ● Issue 3 ● July-September 2012 ● Pages 85-118
    FAQTual

    Arun Bhatt
    Protocol deviation and violation
    President, Clininvent Research Pvt Ltd,
    Mumbai, India

    Address for correspondence:


    Dr. Arun Bhatt,
    Clininvent Research Pvt. Ltd., A-103,
    Everest Chambers,
    Marol Naka, Andheri-Kurla Road,
    Andheri (East) - 400 059,
    Mumbai, Maharashtra, India.
    E-mail: arunbhatt@clininvent.com

    WHAT IS THE DIFFERENCE BETWEEN Norman M. Goldfarb Journal of Clinical Research Best
    PROTOCOL DEVIATION AND PROTOCOL Practices Nov 2005
    • Protocol deviation. A protocol deviation occurs when,
    VIOLATION? without significant consequences, the activities on a study
    diverge from the Institutional Review Board-approved
    Some suggested definitions are as follows:
    protocol, e.g., missing a visit window because the subject
    Food and drug administration is traveling. Not as serious as a protocol violation.
    Compliance Program Guidance Manual • Protocol violation. A divergence from the protocol that
    materially (a) reduces the quality or completeness of the
    Bioresearch monitoring clinical investigators data, (b) makes the Informed Consent Form inaccurate, or
    • A protocol deviation/violation is generally an (c) impacts a subject’s safety, rights, or welfare. Examples
    unplanned excursion from the protocol that is not of protocol violations may include the following:
    implemented or intended as a systematic change
    • Protocol deviation is also used to refer to any other, • Inadequate or delinquent informed consent
    unplanned, instance(s) of protocol noncompliance • Inclusion/exclusion criteria not met
    • Unreported serious adverse events
    EFGCP Audit Working Party 2001 • Improper breaking of the blind
    • Protocol violation: Serious non-compliance – may lead • Use of prohibited medication
    to exclusion of patients from eligibility analysis and/ • Incorrect or missing tests
    or their discontinuation from the study • Mishandled samples
    • Protocol deviation: Less serious non-compliance – may • Multiple visits missed or outside permissible
    not render a patient ineligible windows
    • Materially inadequate record keeping
    • Intentional deviation from protocol, Good Clinical
    Access this article online
    Practice, or regulations by study personnel
    Quick Response Code:
    Website: • Subject repeated non-compliance with study
    www.picronline.org requirements

    DOI: How to cite this article: Bhatt A. Protocol deviation and violation.
    Perspect Clin Res 2012;3:117.
    10.4103/2229-3485.100663
    Source of Support: Nil. Conflict of Interest: None declared.

    117 Perspectives in Clinical Research | July-September 2012 | Vol 3 | Issue 3

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