LoT Number of Characters

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 aspect involves confirming the lengths of table titles, with an adherence to a maximum of 209 characters. 

Purpose

Validates in the LoT the length of the titles, so that it cannot exceed 209 characters (210 is not allowed). 

Applicability 

• 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 

• Empty table
• All files but LoT

Discrepancies

• The number of characters found  is 210 or greater.

Discrepancy Example