protocol deviation
Departure from approved clinical trial procedures that may affect safety or data integrity.
Full Definition
A protocol deviation is any departure from the approved clinical trial protocol that occurs during the conduct of a study. Deviations can range from minor administrative errors to significant violations that may compromise patient safety or data integrity. They must be documented, reported, and evaluated for their impact on the study results. Common types include missed visits, incorrect dosing, enrollment of ineligible patients, or failure to obtain required laboratory tests. Proper management of protocol deviations is essential for regulatory compliance and scientific validity.
Usage
Usage note: Distinguish from protocol amendments, which are pre-approved changes to the study design.
In Context
- "The protocol deviation was classified as minor and did not impact patient safety." — Clinical trial monitoring report
- "All protocol deviations must be documented within 24 hours of discovery." — Standard operating procedure