FAQTUAL

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

Protocol deviation and violation

Arun Bhatt
President, Clininvent Research Pvt Ltd, Mumbai, India

Correspondence Address:
Arun Bhatt
Clininvent Research Pvt. Ltd., A-103, Everest Chambers, Marol Naka, Andheri-Kurla Road, Andheri (East) - 400 059, Mumbai, Maharashtra
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/2229-3485.100663

What is the difference between protocol deviation and protocol violation?

• 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

• 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

• 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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