Protocol Deviation

**Semantic type:** Event

**Definition:** 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. (CDISC Glossary)

**Synonyms:** - DVTERM - DVTERM - Deviation - PROTOCOL DEVIATION - PROTOCOL DEVIATION - protocol deviation