Analysis and reporting
Connect the planned questions to analysis execution, result tables and interpretation. Keep data versions, methods and outputs traceable and document departures from the plan.
Flows for this purpose
- Analysis execution
Dataset version → analysis population → specified method → diagnostics → estimates → interpretation
- Sensitivity and supplementary analyses
Main analysis → assumption perturbation or supplementary question → alternative analysis → comparison
- Safety analysis
Safety population → exposure and observation → event definitions → summaries and comparisons
- Results table specification
Reporting question → population and denominator → rows, columns and statistics → table shell
- Results review and traceability
Analysis output → source and denominator checks → review → resolved output