Performed Protocol Deviation

Definition 1

A variation from process or procedures defined in a study protocol. (NCI Thesaurus)

Definition 2

A variation from process or procedures defined in a study protocol. EXAMPLE(S): Study subject not withdrawn as per protocol, excluded concomitant medication, treatment deviation. NOTE(S): Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety. (NCI Thesaurus/BRIDG)

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