Clinical Study Protocol Deviation

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A Clinical Study Protocol Deviation is a deviation from a clinical protocol specification.



References

2012

  • (Bhatt, 2012) ⇒ Arun Bhatt. (2012). “Protocol Deviation and Violation.” Perspectives in clinical research 3, no. 3
    • QUOTE:
    • 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