LoT Format

Introduction 

The LoT file must be in a specific format in order for the LoT checks to run successfully. If the file does not meet the criteria below, it will be failed, and all LoT-related checks will be marked as Not Applicable.

Key Points  

The name of the LoT file has no meaning.

• Sheet names:
  • For Drug  Projects 
    • Main sheet: One of the following four sheets (only one of these 4 should be present):
      • LoT Phase 1 and Research
      • LoT FD
      • LoT Oncology
      • LoT
    • A Secondary sheet can appear in addition to the main sheet:
      • Other BR and EU
• For Vaccine Projects 
  • Main sheet: 
    • LoT Vaccines
  • Secondary sheet:
    • Vaccines BR and EU
• Column names (not sensitive to column-order):
  • Type
  • Number (can be  TLF Number in vaccine studies)
  • Title
  • Analysis Population
  • File Name
  • Source Datasets

Footnote Validation via LoT: The Table vs LoT check now supports footnote validation. To enable this, add an Identifier column to your LoT Excel file specifying TITLE for title rows or FOOTNOTE[X] (where X is the line number) for footnote rows. You must also include a Text column containing the exact text.