Listing Event Dates

Format Check

Introduction

In clinical studies, listings are an important part of the study submission to the regulatory authorities. The listings contain data regarding the participants when each record is composed of observations which are collected during the study or following each visit during the study. The event dates mentioned in the listings should be earlier than or equal to the cutoff date.

Purpose

Validates that the event dates mentioned in the listings are earlier than or equal to the cutoff date in the footnote. 

Applicability 

Inclusion conditions 

• All listing files in which:
  • There is a column header with the word “Date”
  • Cutoff date is mentioned in the footnotes
• Applicable date formats:
  • Full dates:
    • ddmmmyyyy (month in 3 letters). 
    • yyyy-mm-dd (separated by dashes).
  • Partial dates:
    • mmmyyyy (month in 3 letters) 
    • yyyy-mm (no day)
    • yyyy (only year)

Exclusion 

• Figures, LoT, Mock Shell, Table

Discrepancies

• Specified date is later than the cutoff date.

Discrepancy Example
The cut off date is 08/10/21, so 2022 is a discrepancy.