AESCAN and AESOD may be retained for studies that used those criteria

Rule

VAR-023

Category

Variables demoted

Basis

Confirmed Traceable to the published specification text cited below.

Detectability

Define-XML heuristic The Define-XML indicates this, but does not prove it. Treat the finding as a prompt to check, not as a verdict.

Finding type

Opportunity

Applies to

SDTMIG 3.2, 3.3, 3.4

What changes in v4.0

AESCAN (Involves Cancer) and AESOD (Occurred with Overdose) are present in the v3.4 AE specification table and absent from the v4.0 one, and Appendix E records that the AE assumption text covering them was rewritten. The replacement assumption states that "the SDTM seriousness variables --SCAN (Involves Cancer) and --SOD (Occurred with Overdose) are for seriousness criteria no longer in common use. They may be included for older studies where those criteria were used." They are out of the listed subset because they are dated, not because they are disallowed.

What to do about it

Keep them. Your study collected these criteria, which is exactly the case the assumption preserves them for, and removing them would discard collected safety information to satisfy a rule the standard does not make. Do not carry them into new studies, and note in the reviewer's guide that the criteria are no longer in common use so a reviewer understands why they appear.

What the scan can and cannot see

AESCAN or AESOD being declared is evidence the study used those seriousness criteria, which is the case the AE assumption permits retaining them for - but a declared column may be empty, and whether the criteria were actually collected is record-level.