Table vs LoT

Consistency Against LoT Check

Introduction

Tables are an important part of a study submission to the regulatory authorities, and contain information regarding the data of a study, such as titles, number and source, the same as figures. This information should be equal to the one presented in the LoT. 

Purpose

• Validates that the consistency between LoT file and table/listing of:
  • Number: For drug projects, ensuring consistency between the number in the file and the table/listing. An exception is made for vaccine listings, where the number should start with 16.
  • Title
  • Source
• The file name serves as the identification key for comparison.

Applicability 

Inclusion conditions 

• All tables and listings

Exclusion 

• Empty table
• LoT parsing fail
• Violation of the LoT format
• Figure, ADaM, LoT, Mockshell

Discrepancies

• Missing in LoT
• File appears multiple times in LoT
• Missing characters is source file (title/source data)
• Title mismatch
• Number mismatch
• Source data mismatch

Discrepancy Example