V Sum

Arithmetic Calculation Check

Introduction

In clinical studies, tables present groups that are often divided into subgroups, in which the latter sum up the former. A cell in a table that represents the sum of other cells, must present the right calculated value.

Purpose

Validates that:

• The vertical sum of subgroups matches the value of the subgroup parent
• The vertical sum of percentages for subgroups matches the parent subgroup's percentage value (with an accepted range of error of 0.1)
  
  

Applicability 

Inclusion conditions 

• Tables featuring values and percentages, presented either within the same cell or in separate cells

Exclusion 

• Total represent patients and the subgroups represent events 
• Statistics calculations 
• Values with a decimal point
• Non-numeric values (NA, for example)
• Empty table
• Listing, Figure, ADaM, LoT, Mock Shell
• ONO specific rules: 
  • Adverse events
    • Included in the check when events are counted (and not subjects)
  • Medical history
  • Concomitant medications
  • Protocol deviations
  • Values with a decimal point
  • Non-numeric values (NA, for example)

Discrepancies

• Sum of children does not equal parent

Discrepancy Example