What is a protocol deviation?

• A. Unplanned departure from the protocol.
• B. A clerical error in the log.
• C. A device malfunction unrelated to protocol.
• D. An amendment approved by the sponsor.

Answer: (A)

A protocol deviation is an unplanned departure from the approved protocol and its procedures, meaning the way the study is conducted diverges from what was written in the protocol without a formal amendment. This aligns with the described scenario of an unplanned departure from the protocol. A clerical error in the log is a documentation mistake, not a deviation in how the study is conducted. A device malfunction unrelated to the protocol is an equipment issue, not a deviation from the protocol’s conduct. An amendment approved by the sponsor is a formal, approved change to the protocol, not a deviation from the current protocol. When deviations occur, they should be documented and reported as required, with assessment of their impact on safety or data integrity.