N consistency (with 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 populations have the same size compared to the reference. If an adsl.sas7bdat file type of has been uploaded, the population size is extracted from the ADaM file and utilized as the for this verification process. If no adsl.sas7bdat file type has been uploaded, the  reference table is according to the user choice during project creation/editing.

Applicability 

Inclusion conditions 

• Tables with 
  • The population in the table title. 
  • The population (or synonymous name) should appear in the reference table or in the adsl.sas7bdat ADAM file. 
  • The sample size should appear (N=x) in some/all groups in the table column headers

Exclusion 

• Empty table
• If there are no tables that contain the exact population name, then the tables are flagged as not applicable. 

Discrepancies

• Value mismatch

Discrepancy Example

Table

Reference file