Professional
Technical
In the Industry Vocabulary Test
protocol deviation
Any departure from the approved study protocol that may affect patient safety or data integrity.
Full Definition
A protocol deviation is any departure, intentional or accidental, from the approved clinical trial protocol. In pediatric oncology, deviations can include missed doses, timing variations, incorrect dosing, or failure to meet eligibility criteria. Protocol deviations must be documented, reported, and assessed for impact on patient safety and study outcomes. Major deviations may require immediate reporting to regulatory authorities and ethics committees.
Usage
Usage note: Distinguish from 'protocol amendment' which is a planned change to the protocol.
In Context
- "The delayed chemotherapy administration was classified as a minor protocol deviation." — clinical trial report
- "All protocol deviations must be documented within 48 hours of occurrence." — study procedures manual
Also known as
protocol violation
protocol non-compliance
Contrasted with
protocol adherence
protocol compliance
Don't confuse with
protocol amendment
protocol exception