The plan for the scope of evaluation in a clinical trial is described by which topic?

• A. Set of Subjects to be Evaluated and Presentation of Data
• B. Statistical Evaluation
• C. Scope of Evaluation
• D. Subgroups, Interactions and Covariates

Answer: (C)

Defining what data will be evaluated and how they will be analyzed is captured by the topic Scope of Evaluation. This area lays out the plan for which data and endpoints will be included, which timepoints are relevant, and which analysis populations (for example, the full analysis set or per-protocol set) will be used. It essentially draws the boundaries of the statistical evaluation so the plan is clear before any analysis is done.

Understanding this helps ensure the analysis is pre-specified and objective, rather than shaped after seeing the results. The other topics govern how the data are analyzed (Statistical Evaluation), who is included and how data are summarized (Set of Subjects to be Evaluated and Presentation of Data), and what additional insights might be explored (Subgroups, Interactions and Covariates), but the plan for what falls inside the scope of evaluation itself is described by Scope of Evaluation.