Baseline Hierarchy

Hierarchy Check 

Introduction 

A baseline value is an initial measurement of a condition that is taken at an early time point and used for comparison over time to look for changes. The number of subjects at baseline is the highest value. 

Purpose

Validates that: the number of participants at baseline is greater than or equal to the number of participants in subsequent visits.

Applicability 

Inclusion conditions 

• Applicable to tables that contain the following keywords:
  • “Baseline”, “Screening”, or “SCR” 
    • Row header (note: not column header)
    • Single word in the cell or in brackets 
  • “n”, “N”, “Total” or “TOTAL” 
    • Row header 
    • Column header

Exclusion 

• Empty tables
• Listing, Figure, ADaM, LoT

Discrepancies

• The number of participants in later visits of the study is greater than the number of participants at baseline.

Discrepancy Example

Discrepancy: The number of participants at the 4-week time point is higher than the number of participants at the baseline.