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Perspectives in Clinical Research logoLink to Perspectives in Clinical Research
. 2012 Jul-Sep;3(3):117. doi: 10.4103/2229-3485.100663

Protocol deviation and violation

Arun Bhatt 1,
PMCID: PMC3487227  PMID: 23125964

WHAT IS THE DIFFERENCE BETWEEN PROTOCOL DEVIATION AND PROTOCOL VIOLATION?

Some suggested definitions are as follows:

Food and drug administration

Compliance Program Guidance Manual

Bioresearch monitoring clinical investigators

  • A protocol deviation/violation is generally an unplanned excursion from the protocol that is not implemented or intended as a systematic change

  • Protocol deviation is also used to refer to any other, unplanned, instance(s) of protocol noncompliance

EFGCP Audit Working Party 2001

  • Protocol violation: Serious non-compliance – may lead to exclusion of patients from eligibility analysis and/or their discontinuation from the study

  • Protocol deviation: Less serious non-compliance – may not render a patient ineligible

Norman M. Goldfarb Journal of Clinical Research Best Practices Nov 2005

  • Protocol deviation. A protocol deviation occurs when, without significant consequences, the activities on a study diverge from the Institutional Review Board-approved protocol, e.g., missing a visit window because the subject is traveling. Not as serious as a protocol violation.

  • Protocol violation. A divergence from the protocol that materially (a) reduces the quality or completeness of the data, (b) makes the Informed Consent Form inaccurate, or (c) impacts a subject's safety, rights, or welfare. Examples of protocol violations may include the following:

    • Inadequate or delinquent informed consent
    • Inclusion/exclusion criteria not met
    • Unreported serious adverse events
    • Improper breaking of the blind
    • Use of prohibited medication
    • Incorrect or missing tests
    • Mishandled samples
    • Multiple visits missed or outside permissible windows
    • Materially inadequate record keeping
    • Intentional deviation from protocol, Good Clinical Practice, or regulations by study personnel
    • Subject repeated non-compliance with study requirements

Footnotes

Source of Support: Nil.

Conflict of Interest: None declared.


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