How are deviations typically described in a Final Study Report?

• A. By the deviation's date and reviewer.
• B. By the deviation's nature, cause, effect on data, corrective actions, and assessment of impact on study conclusions.
• C. Only by data variation.
• D. Only by the investigator's opinion.

Answer: (B)

In a Final Study Report, deviations must be described in a way that shows what happened, why it happened, and how it could affect the study. The best approach is to detail the deviation’s nature (what occurred), the cause (why it happened), its effect on the data or results, the corrective actions taken to address it, and an assessment of whether the deviation impacts the study conclusions. This full description ensures traceability, supports objective evaluation, and demonstrates whether study findings remain valid or if amendments or reanalysis are needed.

Describing deviations only by date and reviewer leaves out essential context about what went wrong and how it affected the data and conclusions. Reporting data variation alone misses root cause and required corrective actions. Relying solely on the investigator’s opinion is subjective and does not provide the necessary objective assessment and actions.