DOM-002 · New domains
Adjudication data should move to the new EA domain
- Rule
- DOM-002
- Category
- New domains
- 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
- Heuristic
- Applies to
- SDTMIG 3.2, 3.3, 3.4
What changes in v4.0
v4.0 adds Event Adjudication (EA) as a Findings About domain, with EAEVAL (Evaluator), EAEVALID (Evaluator Identifier), EAACPTFL (Accepted Record Flag), EAMETHOD, EADTC, EADY, EACAT, EALNKID and EALNKGRP. Studies currently carry this content in FA--, custom domains or supplemental qualifiers. A new Cause of Death Adjudication example was also added to the Death Diagnosis and Details (DD) domain.
What to do about it
Remap adjudication content into EA. Not mandatory for legacy studies, but it is the difference between a reviewer finding the adjudication result and not, so it is usually worth doing for anything still recruiting.
What the scan can and cannot see
Matched on the dataset LABEL containing "adjudicat". A label is a proxy for content: it misses adjudication data labelled anything else, and fires on a dataset that merely mentions the word.
Sources
Every claim above rests on one of these. Where a line is from the public-review draft it says so, because a draft can still move.
- SDTMIG v4.0 draft (2026-02-09), Appendix E, New Domains; Section 6.4, Findings About
Does this one apply to your studies?
Open the scanner, then select or drop in a Define-XML file. It checks this rule and the other 46 in your browser; the file is never uploaded.
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