Format Check
Introduction
Within the rigorous landscape of clinical trials, temporal precision is paramount. Every trial, akin to a delicate orchestration, relies on a symphony of dates to maintain coherence and integrity. TLFs contain several dates that should be in a specific order. Ensuring the alignment and accuracy of these dates within TLFs is not just a procedural requirement; it's a fundamental pillar of trial validity.
Purpose
Validates that:
- Snapshot date:
- Is the same as the date inserted by the user in the project setup
- Is the same in all project TLFs (reference table selected automatically by Verify)
- Exists when a cutoff date exists (so that, there can be no cutoff without snapshots)
- Cutoff date:
- Is earlier than or equal to the snapshot date
- Is the same in all project TLFs (reference table selected automatically by Verify)
- SDTM Creation/Table Generation date:
- Is earlier than the snapshot date
- Is missing
Applicability
Inclusion conditions
- All tables, listings and figures
Exclusion
- Empty table
- Mockshell, ADaM, LoT
Discrepancies
- SDTM Creation date is earlier compared to the date inserted by the user
- SDTM Creation date is missing
- Table Generation date is earlier than the date inserted by the user
- Table Generation date is missing
- Snapshot date is not identical to the date inserted by the user
- Snapshot date is missing when cutoff exists
- Cutoff date is later than the Snapshot date (only when snapshot exists)
- Snapshot date is missing - when there’s a snapshot in the reference table
- Cutoff date is missing
- Snapshot date is not identical to the reference table
- Cutoff date is not identical to the reference table
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