If deviations from the original statistical plan occur, what is required for documentation?

• A. Deviations may be omitted from reporting
• B. Deviations must be approved by the sponsor only
• C. Deviations should be described in the protocol
• D. Deviations should be described and justified in the protocol and/or final report as appropriate

Answer: (D)

When deviations from the original statistical plan occur, you must describe and justify them in the protocol and/or final report as appropriate. This keeps the study transparent and lets readers understand how the deviations might affect results, power, bias, and interpretation. If a deviation happens, you may need to amend the protocol or statistical analysis plan and then report the deviation and its impact in the final report. Simply omitting deviations isn’t permissible, and relying on sponsor approval alone doesn’t provide the necessary rationale or documentation. Describing deviations only in the protocol isn’t sufficient for later interpretation; they should be explained and justified in the protocol and/or final report so the study’s findings remain interpretable.