The plan for which variables are collected and how data are gathered is described by which topic?

• A. Subgroups, Interactions and Covariates
• B. Scope of Evaluation
• C. Choice of Variables and Data Collection
• D. Integrated Summary

Answer: (C)

Defining which variables to collect and how data are gathered establishes the data collection plan. This covers selecting the data elements (endpoints, covariates, and other measures) and specifying the methods, sources, timing, and procedures for collecting and handling those data (for example, CRFs, data sources, measurement methods, and data quality controls). That combination ensures consistent, reliable data to support analysis.

The other topics address different areas: planning which statistical subgroups and covariate analyses to consider, outlining what parts of the evaluation are included, or summarizing results across studies. They are not about the concrete plan for data elements and data collection.