The SDTMIG v4.0 rules catalogue

Every finding the impact scanner reports comes from one of these 47 rules. Each one states what v4.0 changes, what to do about it, how conclusively Define-XML alone can detect it, and the specification text it rests on. Read the rule; do not take the result on trust.

Catalogue 0.15.2 targeting SDTMIG v4.0 (public-review) · 47 rules, 38 confirmed against published text · reviewed 2026-09-15

Structural

Rule	What it finds	Basis	Detectability
NS-001	SUPP-- datasets are decommissioned and replaced by NS--	Confirmed	Define-XML conclusive
NS-002	Pooled SUPPQUAL must be split into per-domain NS-- datasets	Confirmed	Define-XML conclusive
NS-003	v4.0 does not say what replaces associated-persons SUPP datasets	Needs verification	External context required
NS-004	NS-- dataset name does not resolve to a standard parent domain	Confirmed	Define-XML conclusive
NS-005	SUPP-- dataset declares no IDVAR, so its parent records are unidentified	Confirmed	Define-XML heuristic
NS-008	RELREC may reference SUPP-- datasets that v4.0 replaces	Confirmed	Data required
NS-009	The NS-- dataset name for this SUPP-- dataset cannot be established	Confirmed	External context required

New domains

Rule	What it finds	Basis	Detectability
DOM-001	New GI domain collides with an existing sponsor-defined GI dataset	Confirmed	Define-XML conclusive
DOM-002	Adjudication data should move to the new EA domain	Confirmed	Define-XML heuristic
DOM-003	Applicability: does the new DC domain apply to this study?	Confirmed	Protocol required
DOM-008	Variable names suggest adjudication content the dataset label does not	Confirmed	Define-XML heuristic

Domains changed

Rule	What it finds	Basis	Detectability
DOM-004	Domain code is not in the SDTMIG v3.4 or v4.0 domain tables	Confirmed	External context required
DOM-005	The PF domain is deprecated in favour of GF	Confirmed	Define-XML conclusive
DOM-006	The Comments (CO) structure text does not match the v4.0 structure	Confirmed	Define-XML conclusive
DOM-007	Domain code uses a prefix the IG reserves for custom domains	Confirmed	Define-XML conclusive

Variables removed

Rule	What it finds	Basis	Detectability
VAR-001	--BLFL has been removed from SDTMIG v4.0	Confirmed	Define-XML conclusive
VAR-022	--RESCAT is removed from the MI and MS specification tables	Confirmed	Define-XML conclusive
VAR-033	TIRL is removed from the TI specification table	Confirmed	Define-XML conclusive
VAR-026	--BODSYS is removed from the Findings model	Confirmed	Define-XML conclusive
VAR-027	--MODIFY is removed from the Findings model	Confirmed	Define-XML conclusive

Variables demoted

Rule	What it finds	Basis	Detectability
VAR-020	--TSTDTL is no longer listed in the MS, OE and UR specifications	Draft	External context required
VAR-021	--DRVFL is no longer listed in the FT and QS specifications	Draft	External context required
VAR-023	AESCAN and AESOD may be retained for studies that used those criteria	Confirmed	Define-XML heuristic
VAR-025	MSDUR is no longer listed in the MS specification	Draft	External context required
VAR-028	RS relative-timing variables are no longer listed in RS	Draft	External context required
VAR-029	SRSPEC is no longer listed in the SR specification	Draft	External context required

Variables changed

Rule	What it finds	Basis	Detectability
VAR-002	--BLFL is declared and no --LOBXFL is declared alongside it	Confirmed	Define-XML conclusive
VAR-003	Variables developed for nonclinical trials, usable with caution	Confirmed	Protocol required
CORE-001	--SPEC is Expected in v4.0 but absent from this dataset	Draft	Define-XML conclusive
CORE-002	RPLOBXFL is Expected in v4.0 but is not declared in this RP dataset	Draft	Define-XML conclusive
CORE-003	TULOBXFL is relaxed to Permissible in v4.0	Draft	Define-XML conclusive

Variables added

Rule	What it finds	Basis	Detectability
ID-001	SUBJID is added to every subject-level domain specification table	Confirmed	Define-XML conclusive
VAR-010	DV can adopt the new DVCLASI deviation classification	Confirmed	Define-XML conclusive
VAR-011	DM can adopt CRACE and CETHNIC for as-collected race and ethnicity	Confirmed	Define-XML conclusive
VAR-012	DM can adopt AGERLO and AGERHI where exact age is unknown	Confirmed	Data required
VAR-013	CM can adopt the CMTRTCD standardised medication code	Confirmed	Define-XML conclusive
VAR-014	EG can adopt the EGRSCNT result count	Confirmed	Define-XML conclusive
VAR-015	QRS domains can adopt the --CBRFL conditionally branched item flag	Confirmed	Define-XML conclusive
VAR-030	Collected race or ethnicity may sit where CRACE and CETHNIC now belong	Confirmed	Define-XML heuristic
VAR-031	A medication code may sit where CMTRTCD now belongs	Confirmed	Define-XML heuristic
VAR-032	Branching information may sit where --CBRFL now belongs	Confirmed	Define-XML heuristic
VAR-017	SV gains SVSEQ	Confirmed	Define-XML conclusive
VAR-034	Optional variables added to domains this study already carries	Confirmed	Define-XML conclusive

Define-XML

Rule	What it finds	Basis	Detectability
NS-006	One QNAM is declared more than once with disagreeing variable metadata	Confirmed	Define-XML conclusive
NS-007	SUPP-- dataset declares no value-level metadata for its QNAM values	Confirmed	Define-XML conclusive
DEF-002	Dataset class is not declared, blocking automated v4.0 mapping	Confirmed	Define-XML conclusive

Process

Rule	What it finds	Basis	Detectability
DEF-001	Applicability: which Define-XML version does this submission need?	Confirmed	External context required

See which of these apply to you

Open the scanner, then select or drop in a Define-XML file. It runs every rule above against it in your browser and tells you which ones fire, on which datasets and variables.

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