What defines a Protocol Deviation in clinical research?

A Protocol Deviation in clinical research refers to an unplanned excursion from the protocol requirements. This means that it involves any instance where the study procedures, participant eligibility, or other plans outlined in the clinical trial protocol are not followed as originally specified.

This definition is critical for ensuring the integrity of the research and maintaining compliance with regulatory standards. It also emphasizes that deviations can have potential implications on the study's validity and safety assessments. Uneventful protocol adherence is essential for the quality of data collected and the efficacy of the trial as a whole, highlighting the importance of recognizing and documenting these deviations.

In contrast, a planned change in study design would not qualify as a deviation since it is anticipated and approved through proper channels. Similarly, requiring new regulatory approval signifies a major modification rather than an unplanned deviation. Changes made with the consent of all participants would typically signify ethical or procedural adjustments that are formally addressed rather than deviations, which are more about non-compliance with established protocol guidelines.