How would you classify a protocol deviation?

How would you classify a protocol deviation?

• A. A departure from the protocol that may or may not affect safety/data integrity, typically minor
• B. A major violation requiring trial termination
• C. A data entry error
• D. An approved protocol amendment

Answer: (A)

A protocol deviation is an unapproved departure from what the protocol specifies. Most deviations are minor, meaning they do not affect participant safety, rights, welfare, or the integrity of the trial data. They’re departures that occur in the conduct of the study and are typically documented and monitored rather than cause for trial termination. Some deviations, however, can be major if they potentially impact safety or data integrity, and those require closer investigation and reporting to the sponsor and ethics oversight bodies, and sometimes a formal protocol amendment or termination of the trial. Data entry errors are separate from protocol conduct issues, and an approved protocol amendment is a formal, pre-approved change to the protocol, not a deviation.

A protocol deviation is an unapproved departure from what the protocol specifies. Most deviations are minor, meaning they do not affect participant safety, rights, welfare, or the integrity of the trial data. They’re departures that occur in the conduct of the study and are typically documented and monitored rather than cause for trial termination. Some deviations, however, can be major if they potentially impact safety or data integrity, and those require closer investigation and reporting to the sponsor and ethics oversight bodies, and sometimes a formal protocol amendment or termination of the trial. Data entry errors are separate from protocol conduct issues, and an approved protocol amendment is a formal, pre-approved change to the protocol, not a deviation.