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Protocol Deviation
Definition 1
An unintended departure from the study plan which has not been prospectively reviewed and approved by the IRB and FDA. (NCI Thesaurus)
Definition 2
A variation from processes or procedures defined in a protocol. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety, and are often acknowledged and accepted in advance by the sponsor. NOTE: Good clinical practice recommends that deviations be summarized by site and by category as part of the report of study results so that the possible importance of the deviations to the findings of the study can be assessed. Compare to protocol violation. [See ICH E3] (NCI Thesaurus/CDISC)
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