CITI Training Practice Exam

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What is a Protocol Deviation?

A planned study change
An unplanned excursion from the protocol requirements
A systematic change in study design
A change requested by a study sponsor

The correct answer is: An unplanned excursion from the protocol requirements

A Protocol Deviation is an unplanned excursion from the set protocol requirements in a study. This means that any actions or deviations that occur during a study that do not align with the set procedures and guidelines are considered protocol deviations. Options A, C, and D are incorrect because they suggest planned or systematic changes to the study, while a protocol deviation is an unplanned occurrence. It is also important to note that a protocol deviation is not necessarily a change requested by a study sponsor but can be any unplanned occurrence that deviates from the set protocol.