The plan outlining what aspects of a trial are to be evaluated is described by which topic?

• A. Scope of Evaluation
• B. Subgroups, Interactions and Covariates
• C. Integrated Summary
• D. Statistical Evaluation

Answer: (A)

The key concept is defining what will be examined in the trial—the scope of evaluation. This plan sets the boundaries for what endpoints, populations, subgroups, time points, covariates, and other aspects will be assessed and reported. By outlining what is included, it determines what analyses will be conducted and prevents scope creep later in the study.

The other topics focus on specific parts of analysis: Subgroups, Interactions and Covariates refers to studying particular analytical nuances within the data; Integrated Summary is the overall synthesis of safety and efficacy across data; Statistical Evaluation concerns the methods used to analyze the data. While related, they are not the overall plan that states what aspects of the trial will be evaluated.