Consistency Between Tables Check
Introduction
In a clinical trial, patients in a specific population should remain the same throughout the reporting event, and all calculations are based on the original denominator, i.e., the number of patients randomized into each group, regardless of subsequent events.
Purpose
Validates that the identical population has the same size throughout the study.
Applicability
Inclusion conditions
- Tables with:
- There is a population in the table title.
- Sample size (N=x) in some/all groups in the table column headers
Exclusion
- Empty table
- Figures, LoT, Mock Shell
Discrepancies
- Value mismatch
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