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Year : 2012  |  Volume : 3  |  Issue : 3  |  Page : 117

Protocol deviation and violation

President, Clininvent Research Pvt Ltd, Mumbai, India

Date of Web Publication5-Sep-2012

Correspondence Address:
Arun Bhatt
Clininvent Research Pvt. Ltd., A-103, Everest Chambers, Marol Naka, Andheri-Kurla Road, Andheri (East) - 400 059, Mumbai, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2229-3485.100663

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How to cite this article:
Bhatt A. Protocol deviation and violation. Perspect Clin Res 2012;3:117

How to cite this URL:
Bhatt A. Protocol deviation and violation. Perspect Clin Res [serial online] 2012 [cited 2023 Mar 30];3:117. Available from: http://www.picronline.org/text.asp?2012/3/3/117/100663

   What is the difference between protocol deviation and protocol violation? Top

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

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