protocol deviation

A variation from the processes or procedures defined in a (clinical study) protocol that usually do not preclude overall evaluability of subject/patient data for efficacy or safety, and are often acknowledged and accepted in advance by the sponsor.
Good clinical practice recommends that deviations be summarised 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.

单词	protocol deviation
释义	protocol deviation protocol deviation A variation from the processes or procedures defined in a (clinical study) protocol that usually do not preclude overall evaluability of subject/patient data for efficacy or safety, and are often acknowledged and accepted in advance by the sponsor. Good clinical practice recommends that deviations be summarised 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.
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