Superscript

Format Check

Introduction

Sometimes the clinical trial file’s footnote contains a reference relating to the main body of text. Footnotes are referenced by certain symbols (*, †, ‡, etc.), letters, or numbers, in superscript form. 

Purpose

Validates that the superscript meets the company-specific format and that the superscript is present both in the table and in the footnotes.

• Pfizer
  • In the table:
    • location: apex
    • Upper case in rounded brackets English letters only
  • In the footnote:
    • Lowercase English letters only
    • Only format permitted, such as: a. 
•  Ono
  •  Both in footnote and table 
    • number with parenthesis, round bracket: 1) 
    • letter with parenthesis, round bracket: a)

Applicability 

Inclusion conditions 

• Tables and listing with superscripts.

Exclusion 

• Empty table
• Figures, Mock Shell, LoT

Discrepancies

• Superscript is missing in the table
• Superscript is missing in footnotes
• Wrong superscript format
• The superscript breaks the alphabetical order

Discrepancy Example

Wrong format 

The letter b is Missing in the table