Which topic focuses on presenting data and identifying the subjects to be evaluated?

• A. Statistical Evaluation
• B. Set of Subjects to be Evaluated and Presentation of Data
• C. Integrity of Data and Computer Software Validity
• D. Reporting

Answer: (B)

This topic focuses on both who will be studied and how the results will be shown. In ICH GCP and related study materials, it covers the set of subjects to be evaluated (defining the study population, inclusion/exclusion criteria, recruitment, consent) and the presentation of data (how outcomes will be summarized and displayed in tables, graphs, and summaries). This direct pairing of identifying the subjects and outlining how data will be presented makes it the best fit for the question. The other topics center on analysis methods (statistical evaluation), ensuring data quality and software validity (integrity of data and computer software validity), or the communication of results (reporting), but do not simultaneously address both key elements.