LoT Uniqueness

Format Check

Introduction 

The Lot of Tables (LoT) serves as a crucial component in FDA submissions, providing a structured list of tables essential for regulatory review. Ensuring the accuracy and compliance of this list is paramount to maintaining the integrity of the submission. One key involves confirming that there are no duplicates in the titles or in the numbers. 

Purpose

Validates that the LoT does not contain duplicates in titles or numbers. 

Applicability 

Inclusion conditions 

• LoT table
• In order to proceed with the check, the LoT parsing must have been successful. Any violation the format will result in a ‘failed LoT’, and all LoT-related checks will be ‘Not Applicable’

Exclusion 

• All files but LoT

Discrepancies 

There is a duplicate table number or title. 

Discrepancy Example

Example Table: This table shows a discrepancy of duplicate table numbers in the LoT file