What are "protocol deviations"?

"Protocol deviations" refer to instances where the conduct of a clinical trial does not align with the established study protocol. The protocol serves as a detailed plan that outlines the methodology, objectives, and procedures to be followed in a clinical trial. When any activity, procedure, or guideline specified in this protocol is not adhered to, it constitutes a deviation.

These deviations can occur for multiple reasons and can vary in significance. Some deviations may be minor and have little impact on the study’s outcomes, while others might significantly affect the reliability and validity of the trial results. Maintaining adherence to the protocol is critical for ensuring the integrity of the study findings and for regulatory compliance.

Options referring to changes in trial design, adjustments made for patient well-being, or errors in data collection do not encompass the definition of protocol deviations. While these factors can be relevant in a clinical trial context, they do not specifically describe instances in which the protocol itself is not followed. Thus, instances where the trial conduct does not follow the protocol is the correct and precise identification of protocol deviations.