CDISC for AI · Worked example · early, exploratory work (October 2026)

Who rates?

One terminology change, four places that carry part of its meaning, and no link between them. A worked example of what flat standards leave implicit, and what an explicit graph would state.

Between SDTM Controlled Terminology 2026-03-27 and 2026-09-25 four instrument codelists changed class. Three Clinical Global Impression variants moved from Questionnaire to Clinical Classification, and the Lansky Play-Performance Status Scale moved the other way. Where NCIt states who rates the instrument, each move follows the rater. Yet the rater is not recorded anywhere as data.

What changed

CodelistInstrumentMoveWho rates, per NCIt
LPPSS1TCLansky Play-Performance Status ScaleClinical Classification → Questionnaireparent (C38144)
ACGC01TCADCS Clinical Global Impression of ChangeQuestionnaire → Clinical Classificationclinician (C103515)
CGI02TCClinical Global Impression, generic modificationQuestionnaire → Clinical Classificationclinician (C135738)
GCGI01TCGeneral Clinical Global ImpressionsQuestionnaire → Clinical Classificationnot stated

The CDISC definition of the Clinical Classification domain (C228234) says these instruments are "based on a trained healthcare professional's observation and clinical judgement". A parent-rated scale does not fit; clinician-rated ones do.

Today and envisioned: the Lansky codelist

Today — four places, no links

Codelist C138215 LPPSS1TC · CDISC Questionnaire LPSS Test Code Terminology synonym still: CC-LPSS TESTCD Container C138263 question grouping concept "LPSS Clinical Classification Question" Instrument C38144 Lansky Play-Performance Status under C20641 Performance Status "a parent-rated instrument…" rater only in definition text Domain C228234 Clinical Classification (CC) CDISC definition: "trained healthcare professional's observation and judgement" no link The class is carried only in names and synonyms. Rater, class rule and leftovers are never compared.

Each concept is correct on its own terms. The rater, the class rule and the leftover names from the earlier class sit in text, in different places.

Envisioned — stated and linked

Codelist C138215LPPSS1TC Instrument C38144Lansky Play-Performance Rater: parenta role, not a sentence Class: Questionnairein SDTM CT 2026-09-25 Domain C228234 Clinical Classificationrequires rater: healthcare professional → a parent-rated instrument cannot be CC codelist of rated by classified as checked against

The rater and the class become statements that can be queried and checked. A container still named after the old class, or a parent-rated instrument in Clinical Classification, shows up as a failed check, not as something a reader has to notice.

The same leftovers in all four

Each move renamed the codelists. The question container concept and an old synonym still carry the earlier class.

CodelistClass nowSynonym still carriedContainer concept, as namedInstrument concept
LPPSS1TCQuestionnaireCC-LPSS TESTCDC138263 LPSS Clinical Classification QuestionC38144, not linked to the codelist
ACGC01TCClinical ClassificationQS-ADCS-CGIC TESTCDC103490 ADCS-CGIC Questionnaire QuestionC103515, renamed, under C118969
GCGI01TCClinical ClassificationQS-GCGI TESTCDC105145 GCGI Questionnaire Questionnone found
CGI02TCClinical ClassificationQS-CGI Generic Modification Version TESTCDC135705 CGI Generic Modification Version Questionnaire QuestionC135738, renamed, under C118969

C118969 is Clinical or Research Assessment Classification. For Lansky, the instrument concept with the rater sits under Performance Status (C20641).

What the explicit version could look like

An illustration in Turtle. The NCIt identifiers are real; the ex: predicates and classes are placeholders. Choosing them, ideally from established ontologies, is the open work.

@prefix ncit: <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#> .
@prefix ex:   <https://example.org/illustrative#> .

ncit:C138215  ex:codelistOf     ncit:C38144 .            # LPPSS1TC → Lansky Play-Performance Status
ncit:C38144   ex:ratedBy        ex:Parent ;
              ex:classifiedAs   ex:Questionnaire .         # in SDTM CT 2026-09-25
ncit:C228234  ex:requiresRater  ex:HealthcareProfessional . # Clinical Classification domain
ncit:C138263  ex:containerFor   ncit:C138215 .           # still labelled "Clinical Classification Question"

With statements like these, two questions become queries: which instruments are clinician-rated? and does any instrument's class contradict its rater, or its container? A change note can then say what a reclassification means — the rater did not fit the class — and not only which labels changed.

Sources: NCI EVS SDTM Terminology 2026-09-25 and 2026-03-27; NCI Thesaurus as used in the repository. Instrument–codelist matches from SDTM_Instrument_Identity.xlsx.