Which topic encompasses trial monitoring and interim analyses?

• A. Data Capture and Processing
• B. Changes in Inclusion and Exclusion Criteria
• C. Sample Size
• D. Trial Monitoring and Interim Analysis

Answer: (D)

Trial monitoring and interim analyses focus on ongoing oversight of how a trial is run, ensuring participant safety and data quality, along with planned analyses of accumulating data at predefined points to decide whether to continue, modify, or stop the study. Monitoring activities include routine checks of protocol adherence, safety reporting, and data integrity, while interim analyses involve looking at interim results under pre-specified rules, often with a data monitoring committee to guard against bias. This combination is distinct from data capture and processing (which is about how data are collected and managed), changes in inclusion and exclusion criteria (which relate to protocol amendments and eligibility rules), or sample size planning (which concerns the initial design and power calculation).