N consistency (without reference)

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

Discrepancy Example
In the first Table, the population is “safety population”. 120 subjects got “Drug A”

In the second Table, the population is the same (“safety population”) . 121 subjects got “Drug A”