Perspectives in Clinical Research

: 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

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

How to cite this URL:
Bhatt A. Protocol deviation and violation. Perspect Clin Res [serial online] 2012 [cited 2023 Feb 1 ];3:117-117
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Full Text

 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 studyProtocol 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 metUnreported serious adverse eventsImproper breaking of the blindUse of prohibited medication Incorrect or missing tests Mishandled samples Multiple visits missed or outside permissible windowsMaterially inadequate record keepingIntentional deviation from protocol, Good Clinical Practice, or regulations by study personnelSubject repeated non-compliance with study requirements