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