CDISC Submission Conformance

Regulatory submissions require that every dataset in a study package passes CDISC conformance rules. Pointblank provides a built-in conformance engine that checks your SDTM datasets against the full SDTMIG rule catalog with no external dependencies (no subprocess, no CLI, no network). For those preparing a final submission gate, Pointblank can also delegate to the external CDISC CORE engine.

Two engines are available:

• Built-in (primary): Pointblank’s own engine runs 426 SDTMIG 3.4 rules against your datasets in-process. Results are immediately renderable in a notebook. No installation beyond Pointblank is required.
• CORE (advanced): delegates to the open-source CDISC CORE CLI, which runs the authoritative CDISC-certified rule set. Requires the CORE executable to be installed separately.

SDTMIG Conformance

The built-in engine covers the complete SDTMIG 3.4 rule catalog, spanning per-record value checks, variable metadata, dataset-level constraints, domain presence, and Define-XML cross-references. The sections below walk through the three output surfaces (the tabular conformance report, the record-level findings table, and the programmatic findings DataFrame) and describe the rule catalog, controlled terminology handling, and optional inputs such as custom CT packages and Define-XML.

Quick Start

validate_sdtmig() is the entry point for SDTMIG conformance. Pass a dictionary mapping domain names to DataFrames and it returns a ConformanceReport that renders as a color-coded summary table in Jupyter and Quarto notebooks:

import polars as pl
import pointblank as pb

dm = pl.DataFrame({
    "STUDYID": ["STUDY01"] * 4,
    "DOMAIN":  ["DM"] * 4,
    "USUBJID": ["STUDY01-01-001", "STUDY01-01-002", "STUDY01-01-003", "STUDY01-01-004"],
    "SUBJID":  ["001", "002", "003", "004"],
    "RFSTDTC": ["2024-01-15", "2024-01-16", "2024-01-17", "2024-01-18"],
    "SEX":     ["M", "F", "M", "F"],
    "RACE":    ["WHITE", "ASIAN", "WHITE", "BLACK OR AFRICAN AMERICAN"],
    "ETHNIC":  ["NOT HISPANIC OR LATINO"] * 4,
    "ARMCD":   ["TRT", "PBO", "TRT", "PBO"],
    "ARM":     ["Treatment", "Placebo", "Treatment", "Placebo"],
    "COUNTRY": ["USA"] * 4,
    "AGE":     [45, 62, 38, 55],
    "AGEU":    ["YEARS"] * 4,
    "DMDTC":   ["2024-01-10"] * 4,
    "DMDY":    [1] * 4,
    "SITEID":  ["01"] * 4,
})

report = pb.validate_sdtmig({"DM": dm})
report

CDISC Conformance FAIL
SDTMIG 3-4 · 410 passed · 4 failed · 12 n/a
	Rule	Domain	Type	Issues	Description
#FF3300	SDTM-033	DM	Variable	1	DM domain must contain RFSTDTC and RFENDTC (reference start/end dates).
#FF3300	SDTM-035	DM	Variable	1	DM domain must contain treatment arm variables (ARMCD, ARM, ACTARMCD, ACTARM).
#FF3300	SDTM-121	TS	Domain	1	TS domain must be present in every SDTM submission.
#FF3300	SDTM-122	TA	Domain	1	TA domain must be present in every SDTM submission.
#4CA64C	SDTM-001	DM	Domain	0	DM (Demographics) domain is required in every SDTM submission.
#4CA64C	SDTM-002	DM	Record	0	STUDYID must not be null in any domain.
#4CA64C	SDTM-003	DM	Record	0	DOMAIN must not be null in any SDTM dataset.
#4CA64C	SDTM-004	DM	Record	0	USUBJID must not be null in any SDTM dataset.
#4CA64C	SDTM-005	DM	Dataset	0	STUDYID must be consistent (same value) across all records in a dataset.
#4CA64C	SDTM-006	DM	Dataset	0	DOMAIN must be consistent (same value) across all records in a dataset.
#4CA64C	SDTM-007	DM	Record	0	SEX in DM must use values from the CDISC controlled terminology codelist SEX.
#4CA64C	SDTM-008	DM	Record	0	RACE in DM must use values from the CDISC controlled terminology codelist RACE.
#4CA64C	SDTM-009	DM	Record	0	COUNTRY in DM must use ISO 3166 alpha-3 country codes (CDISC COUNTRY codelist).
#4CA64C	SDTM-010	DM	Record	0	DMDTC in DM must be in ISO 8601 extended datetime format.
#4CA64C	SDTM-011	DM	Record	0	RFSTDTC in DM must be in ISO 8601 extended datetime format when present.
#4CA64C	SDTM-012	DM	Record	0	RFENDTC in DM must be in ISO 8601 extended datetime format when present.
#4CA64C	SDTM-013	DM	Record	0	DTHDTC in DM must be in ISO 8601 extended datetime format when present.
#4CA64C	SDTM-014	DM	Record	0	DTHFL in DM must use values from the NY codelist (Y or null).
#4CA64C	SDTM-015	DM	Record	0	SUBJID must not be null in DM.
#4CA64C	SDTM-016	AE	Record	0	AETERM must not be null in AE.
#4CA64C	SDTM-017	AE	Record	0	AEDECOD must not be null in AE.
#4CA64C	SDTM-018	AE	Record	0	AESTDTC in AE must be in ISO 8601 extended datetime format when present.
#4CA64C	SDTM-019	AE	Record	0	AEENDTC in AE must be in ISO 8601 extended datetime format when present.
#4CA64C	SDTM-020	AE	Record	0	AESER in AE must use values from the NY codelist when present.
#4CA64C	SDTM-021	AE	Record	0	AEOUT in AE must use values from the AEOUT codelist when present.
#4CA64C	SDTM-022	LB	Record	0	LBDTC in LB must be in ISO 8601 extended datetime format when present.
#4CA64C	SDTM-023	LB	Record	0	LBTEST must not be null in LB.
#4CA64C	SDTM-024	LB	Record	0	LBTESTCD must not be null in LB.
#4CA64C	SDTM-025	VS	Record	0	VSTEST must not be null in VS.
#4CA64C	SDTM-026	VS	Record	0	VSDTC in VS must be in ISO 8601 extended datetime format when present.
#4CA64C	SDTM-027	DM	Metadata	0	USUBJID must be present in every subject-level SDTM domain.
#4CA64C	SDTM-028	DM	Metadata	0	STUDYID must be present in every SDTM domain.
#4CA64C	SDTM-029	DM	Metadata	0	DOMAIN must be present in every SDTM domain.
#4CA64C	SDTM-030	DM	Record	0	ETHNIC in DM must use values from the ETHNIC codelist when present.
#4CA64C	SDTM-031	DM	Variable	0	DM domain must contain all required Identifier and Topic variables.
#4CA64C	SDTM-032	DM	Variable	0	DM domain must contain required demographic variables (SEX, RACE, ETHNIC, COUNTRY).
#4CA64C	SDTM-034	DM	Variable	0	DM domain must contain SITEID, AGE, and AGEU.
#4CA64C	SDTM-036	AE	Variable	0	AE domain must contain required Identifier and sequence variables.
#4CA64C	SDTM-037	AE	Variable	0	AE domain must contain the AE term and dictionary-derived variables.
#4CA64C	SDTM-038	AE	Variable	0	AE domain must contain severity, seriousness, and outcome variables.
#4CA64C	SDTM-039	VS	Variable	0	VS domain must contain required Identifier and test variables.
#4CA64C	SDTM-040	VS	Variable	0	VS domain must contain result variables (VSORRES, VSORRESU, VSSTRESC, VSSTRESN, VSSTRESU).
#4CA64C	SDTM-041	LB	Variable	0	LB domain must contain required Identifier and test variables.
#4CA64C	SDTM-042	LB	Variable	0	LB domain must contain result variables (LBORRES, LBORRESU, LBSTRESC, LBSTRESN, LBSTRESU).
#4CA64C	SDTM-043	EG	Variable	0	EG domain must contain required Identifier and test variables.
#4CA64C	SDTM-044	DM	Variable	0	In any domain, STUDYID must appear before DOMAIN, which must appear before USUBJID.
#4CA64C	SDTM-045	VS	Variable	0	In findings domains (VS, LB, EG), the sequence variable (xSEQ) must appear after USUBJID.
#4CA64C	SDTM-046	DM	Variable	0	In DM, AGE must be a numeric variable.
#4CA64C	SDTM-047	VS	Variable	0	In VS, VSSTRESN must be a numeric variable.
#4CA64C	SDTM-048	LB	Variable	0	In LB, LBSTRESN must be a numeric variable.
#4CA64C	SDTM-061	DM	Record	0	AGEU in DM must use AGEU codelist when present.
#4CA64C	SDTM-062	DM	Record	0	BRTHDTC in DM must conform to ISO 8601 when present.
#4CA64C	SDTM-063	EX	Record	0	EXTRT must not be null in EX.
#4CA64C	SDTM-064	EX	Record	0	EXSTDTC in EX must conform to ISO 8601 when present.
#4CA64C	SDTM-065	EX	Record	0	EXENDTC in EX must conform to ISO 8601 when present.
#4CA64C	SDTM-066	EX	Record	0	EXDOSFRQ in EX must use FREQ codelist when present.
#4CA64C	SDTM-067	EX	Record	0	EXROUTE in EX must use ROUTE codelist when present.
#4CA64C	SDTM-068	EX	Record	0	EXDOSFRM in EX must use FRM codelist when present.
#4CA64C	SDTM-069	CM	Record	0	CMTRT must not be null in CM.
#4CA64C	SDTM-070	CM	Record	0	CMSTDTC in CM must conform to ISO 8601 when present.
#4CA64C	SDTM-071	CM	Record	0	CMENDTC in CM must conform to ISO 8601 when present.
#4CA64C	SDTM-072	CM	Record	0	CMROUTE in CM must use ROUTE codelist when present.
#4CA64C	SDTM-073	DS	Record	0	DSTERM must not be null in DS.
#4CA64C	SDTM-074	DS	Record	0	DSDECOD must not be null in DS.
#4CA64C	SDTM-075	DS	Record	0	DSSTDTC in DS must conform to ISO 8601 when present.
#4CA64C	SDTM-076	DS	Record	0	DSSEQ must not be null in DS.
#4CA64C	SDTM-077	MH	Record	0	MHTERM must not be null in MH.
#4CA64C	SDTM-078	MH	Record	0	MHSTDTC in MH must conform to ISO 8601 when present.
#4CA64C	SDTM-079	MH	Record	0	MHENDTC in MH must conform to ISO 8601 when present.
#4CA64C	SDTM-080	SV	Record	0	VISITNUM must not be null in SV.
#4CA64C	SDTM-081	SV	Record	0	SVSTDTC in SV must conform to ISO 8601 when present.
#4CA64C	SDTM-082	SV	Record	0	SVENDTC in SV must conform to ISO 8601 when present.
#4CA64C	SDTM-083	EG	Record	0	EGTEST must not be null in EG.
#4CA64C	SDTM-084	EG	Record	0	EGTESTCD must not be null in EG.
#4CA64C	SDTM-085	EG	Record	0	EGDTC in EG must conform to ISO 8601 when present.
#4CA64C	SDTM-086	AE	Record	0	AESEV in AE must use AESEV codelist when present.
#4CA64C	SDTM-087	AE	Record	0	AETOXGR in AE must use AETOXGR codelist when present.
#4CA64C	SDTM-088	AE	Record	0	AEBODSYS must not be null in AE.
#4CA64C	SDTM-089	AE	Record	0	AEACN in AE must use AEACN codelist when present.
#4CA64C	SDTM-090	AE	Record	0	AESEQ must not be null in AE.
#4CA64C	SDTM-091	VS	Record	0	VSTESTCD must not be null in VS.
#4CA64C	SDTM-092	VS	Record	0	VSSTRESU in VS must use VSRESU codelist when present.
#4CA64C	SDTM-093	VS	Record	0	VSBLFL in VS must use NY codelist when present.
#4CA64C	SDTM-094	LB	Record	0	LBSTRESU in LB must use LBSTRESU codelist when present.
#4CA64C	SDTM-095	LB	Record	0	LBBLFL in LB must use NY codelist when present.
#4CA64C	SDTM-096	LB	Record	0	LBNRIND in LB must use NRIND codelist when present.
#4CA64C	SDTM-097	PE	Record	0	PETEST must not be null in PE.
#4CA64C	SDTM-098	PE	Record	0	PEDTC in PE must conform to ISO 8601 when present.
#4CA64C	SDTM-099	IE	Record	0	IETEST must not be null in IE.
#4CA64C	SDTM-100	IE	Record	0	IECAT in IE must use IECAT codelist when present.
#4CA64C	SDTM-101	SUPP--	Record	0	RDOMAIN must not be null in SUPP-- datasets.
#4CA64C	SDTM-102	SUPP--	Record	0	QNAM must not be null in SUPP-- datasets.
#4CA64C	SDTM-103	SUPP--	Record	0	QLABEL must not be null in SUPP-- datasets.
#4CA64C	SDTM-104	TS	Record	0	TSPARMCD must not be null in TS.
#4CA64C	SDTM-105	TS	Record	0	TSPARM must not be null in TS.
#4CA64C	SDTM-106	DM	Dataset	0	STUDYID must be consistent (same value) across all records within each domain.
#4CA64C	SDTM-107	DM	Dataset	0	DOMAIN must be consistent (same value) across all records within each dataset.
#4CA64C	SDTM-108	EX	Variable	0	EX domain must contain required identifier and treatment variables.
#4CA64C	SDTM-109	EX	Variable	0	EX domain must contain timing variables EXSTDTC and EXENDTC.
#4CA64C	SDTM-110	CM	Variable	0	CM domain must contain required identifier and treatment variables.
#4CA64C	SDTM-111	CM	Variable	0	CM domain must contain timing variables CMSTDTC and CMENDTC.
#4CA64C	SDTM-112	DS	Variable	0	DS domain must contain required identifier and disposition variables.
#4CA64C	SDTM-113	MH	Variable	0	MH domain must contain required identifier and history variables.
#4CA64C	SDTM-114	SV	Variable	0	SV domain must contain required identifier and visit variables.
#4CA64C	SDTM-115	TS	Variable	0	TS domain must contain required parameter variables.
#4CA64C	SDTM-116	IE	Variable	0	IE domain must contain required inclusion/exclusion criteria variables.
#4CA64C	SDTM-117	PE	Variable	0	PE domain must contain required physical examination variables.
#4CA64C	SDTM-118	EX	Variable	0	EXDOSE must be a numeric variable in EX.
#4CA64C	SDTM-119	SV	Variable	0	VISITNUM must be a numeric variable in SV.
#4CA64C	SDTM-120	EG	Variable	0	EGSTRESN must be a numeric variable in EG.
#4CA64C	SDTM-123	TA	Record	0	ARMCD must not be null in TA.
#4CA64C	SDTM-124	TA	Record	0	ARM must not be null in TA.
#4CA64C	SDTM-125	TA	Record	0	TAETORD must not be null in TA.
#4CA64C	SDTM-126	TA	Record	0	EPOCH must not be null in TA.
#4CA64C	SDTM-127	TE	Record	0	ETCD must not be null in TE.
#4CA64C	SDTM-128	TE	Record	0	ELEMENT must not be null in TE.
#4CA64C	SDTM-129	TV	Record	0	VISITNUM must not be null in TV.
#4CA64C	SDTM-130	TV	Record	0	VISIT must not be null in TV.
#4CA64C	SDTM-131	TI	Record	0	IETESTCD must not be null in TI.
#4CA64C	SDTM-132	TI	Record	0	IETEST must not be null in TI.
#4CA64C	SDTM-133	TI	Record	0	IECAT in TI must use IECAT controlled terminology when present.
#4CA64C	SDTM-134	TI	Record	0	IEINCLCR in TI must use NY controlled terminology when present.
#4CA64C	SDTM-135	AE	Record	0	AEREL in AE must use AEREL controlled terminology when present.
#4CA64C	SDTM-136	AE	Record	0	AESDTH in AE must use NY controlled terminology when present.
#4CA64C	SDTM-137	AE	Record	0	AESHOSP in AE must use NY controlled terminology when present.
#4CA64C	SDTM-138	AE	Record	0	AESLIFE in AE must use NY controlled terminology when present.
#4CA64C	SDTM-139	EX	Record	0	EXSEQ must not be null in EX.
#4CA64C	SDTM-140	CM	Record	0	CMSEQ must not be null in CM.
#4CA64C	SDTM-141	MH	Record	0	MHSEQ must not be null in MH.
#4CA64C	SDTM-142	EG	Record	0	EGSEQ must not be null in EG.
#4CA64C	SDTM-143	VS	Record	0	VSSEQ must not be null in VS.
#4CA64C	SDTM-144	LB	Record	0	LBSEQ must not be null in LB.
#4CA64C	SDTM-145	PE	Record	0	PESEQ must not be null in PE.
#4CA64C	SDTM-146	IE	Record	0	IESEQ must not be null in IE.
#4CA64C	SDTM-147	AE	Dataset	0	AESEQ must be unique within USUBJID in AE.
#4CA64C	SDTM-148	EX	Dataset	0	EXSEQ must be unique within USUBJID in EX.
#4CA64C	SDTM-149	CM	Dataset	0	CMSEQ must be unique within USUBJID in CM.
#4CA64C	SDTM-150	LB	Dataset	0	LBSEQ must be unique within USUBJID in LB.
#4CA64C	SDTM-151	VS	Dataset	0	VSSEQ must be unique within USUBJID in VS.
#4CA64C	SDTM-152	AE	Variable	0	AESTDY must be numeric type in AE.
#4CA64C	SDTM-153	AE	Variable	0	AEENDY must be numeric type in AE.
#4CA64C	SDTM-154	LB	Variable	0	LBDY must be numeric type in LB.
#4CA64C	SDTM-155	VS	Variable	0	VSDY must be numeric type in VS.
#4CA64C	SDTM-156	EX	Variable	0	EXSTDY must be numeric type in EX.
#4CA64C	SDTM-157	CM	Variable	0	CMSTDY must be numeric type in CM.
#4CA64C	SDTM-158	TA	Variable	0	TA must contain required variables: STUDYID, DOMAIN, ARMCD, ARM, TAETORD, EPOCH, ELEMENT.
#4CA64C	SDTM-159	TE	Variable	0	TE must contain required variables: STUDYID, DOMAIN, ETCD, ELEMENT.
#4CA64C	SDTM-160	TV	Variable	0	TV must contain required variables: STUDYID, DOMAIN, VISITNUM, VISIT.
#4CA64C	SDTM-161	TI	Variable	0	TI must contain required variables: STUDYID, DOMAIN, IETESTCD, IETEST, IECAT, IEINCLCR.
#4CA64C	SDTM-162	AE	Variable	0	VISITNUM must be present in AE.
#4CA64C	SDTM-163	VS	Variable	0	VISITNUM must be present in VS.
#4CA64C	SDTM-164	LB	Variable	0	VISITNUM must be present in LB.
#4CA64C	SDTM-165	EG	Variable	0	VISITNUM must be present in EG.
#4CA64C	SDTM-166	SUPP--	Record	0	QVAL must not be null in SUPP-- supplemental qualifier datasets.
#4CA64C	SDTM-167	TS	Record	0	TSSEQ must not be null in TS.
#4CA64C	SDTM-168	LB	Variable	0	LBSTNRLO must be numeric type in LB.
#4CA64C	SDTM-169	LB	Variable	0	LBSTNRHI must be numeric type in LB.
#4CA64C	SDTM-170	LB	Variable	0	LBORNRLO must be numeric type in LB.
#4CA64C	SDTM-171	LB	Variable	0	LBORNRHI must be numeric type in LB.
#4CA64C	SDTM-172	AE	Variable	0	AESEQ must be numeric type in AE.
#4CA64C	SDTM-173	EX	Variable	0	EXSEQ must be numeric type in EX.
#4CA64C	SDTM-174	CM	Variable	0	CMSEQ must be numeric type in CM.
#4CA64C	SDTM-175	MH	Variable	0	MHSEQ must be numeric type in MH.
#4CA64C	SDTM-176	VS	Variable	0	VSSEQ must be numeric type in VS.
#4CA64C	SDTM-177	LB	Variable	0	LBSEQ must be numeric type in LB.
#4CA64C	SDTM-178	EG	Variable	0	EGSEQ must be numeric type in EG.
#4CA64C	SDTM-179	PE	Variable	0	PESEQ must be numeric type in PE.
#4CA64C	SDTM-180	DS	Variable	0	DSSEQ must be numeric type in DS.
#4CA64C	SDTM-181	DM	Record	0	DOMAIN column value must equal 'DM' in the DM dataset.
#4CA64C	SDTM-182	AE	Record	0	DOMAIN column value must equal 'AE' in the AE dataset.
#4CA64C	SDTM-183	LB	Record	0	DOMAIN column value must equal 'LB' in the LB dataset.
#4CA64C	SDTM-184	VS	Record	0	DOMAIN column value must equal 'VS' in the VS dataset.
#4CA64C	SDTM-185	EX	Record	0	DOMAIN column value must equal 'EX' in the EX dataset.
#4CA64C	SDTM-186	CM	Record	0	DOMAIN column value must equal 'CM' in the CM dataset.
#4CA64C	SDTM-187	DS	Record	0	DOMAIN column value must equal 'DS' in the DS dataset.
#4CA64C	SDTM-188	MH	Record	0	DOMAIN column value must equal 'MH' in the MH dataset.
#4CA64C	SDTM-189	EG	Record	0	DOMAIN column value must equal 'EG' in the EG dataset.
#4CA64C	SDTM-190	TA	Record	0	DOMAIN column value must equal 'TA' in the TA dataset.
#4CA64C	SDTM-191	DM	Record	0	RFXSTDTC in DM must conform to ISO 8601 format when present (date of first exposure to trial treatment).
#4CA64C	SDTM-192	DM	Record	0	RFXENDTC in DM must conform to ISO 8601 format when present (date of last exposure to trial treatment).
#4CA64C	SDTM-193	DM	Record	0	RFICDTC in DM must conform to ISO 8601 format when present (date of informed consent).
#4CA64C	SDTM-194	DM	Record	0	RFPENDTC in DM must conform to ISO 8601 format when present (date of end of participation).
#4CA64C	SDTM-195	DM	Record	0	AGE must not be negative in the DM dataset.
#4CA64C	SDTM-196	DM	Record	0	DMSEQ must not be null in the DM dataset.
#4CA64C	SDTM-197	AE	Record	0	AESCONG (congenital anomaly flag) must use the NY codelist when present in AE.
#4CA64C	SDTM-198	AE	Record	0	AESDISAB (disability flag) must use the NY codelist when present in AE.
#4CA64C	SDTM-199	AE	Record	0	AESMIE (important medical event flag) must use the NY codelist when present in AE.
#4CA64C	SDTM-200	AE	Record	0	AECONTRT (concomitant treatment given flag) must use the NY codelist when present in AE.
#4CA64C	SDTM-201	MH	Record	0	MHDECOD (dictionary-derived term) must not be null in MH.
#4CA64C	SDTM-202	MH	Record	0	MHPRESP (pre-specified) must use the NY codelist when present in MH.
#4CA64C	SDTM-203	MH	Record	0	MHOCCUR (occurrence) must use the NY codelist when present in MH.
#4CA64C	SDTM-204	EX	Record	0	EXOCCUR (occurrence) must use the NY codelist when present in EX.
#4CA64C	SDTM-205	EX	Variable	0	EXDOSTOT (total cumulative dose) must be a numeric variable in EX.
#4CA64C	SDTM-206	EX	Variable	0	EXDOSNO (dose number in a sequence) must be a numeric variable in EX.
#4CA64C	SDTM-207	CM	Record	0	CMOCCUR (occurrence) must use the NY codelist when present in CM.
#4CA64C	SDTM-208	CM	Variable	0	CMDOSE (dose per administration) must be a numeric variable in CM.
#4CA64C	SDTM-209	DS	Record	0	DSCAT (category) must not be null in the DS dataset.
#4CA64C	SDTM-210	DS	Variable	0	DSSTDY (study day of disposition event) must be a numeric variable in DS.
#4CA64C	SDTM-211	PE	Record	0	PETESTCD (test short name) must not be null in the PE dataset.
#4CA64C	SDTM-212	PE	Variable	0	PESTRESN (numeric result in standard units) must be a numeric variable in PE.
#4CA64C	SDTM-213	IE	Record	0	IEORRES (original result) must not be null in the IE dataset.
#4CA64C	SDTM-214	IE	Record	0	IEDTC (date/time of IE assessment) must conform to ISO 8601 format when present in IE.
#4CA64C	SDTM-215	SV	Variable	0	SVSTDY (study day of visit start) must be a numeric variable in SV.
#4CA64C	SDTM-216	SV	Variable	0	SVENDY (study day of visit end) must be a numeric variable in SV.
#4CA64C	SDTM-217	TS	Record	0	TSVAL (parameter value) must not be null in the TS dataset.
#4CA64C	SDTM-218	TS	Variable	0	TSSEQ (sequence number) must be a numeric variable in TS.
#4CA64C	SDTM-219	LB	Record	0	LBFAST (fasting status) must use the NY codelist when present in LB.
#4CA64C	SDTM-220	LB	Record	0	LBCLSIG (clinically significant) must use the NY codelist when present in LB.
#4CA64C	SDTM-221	LB	Variable	0	LBLLOQ (lower limit of quantification) must be a numeric variable in LB.
#4CA64C	SDTM-222	TE	Record	0	TESTRL (trial element start rule) must not be null in the TE dataset.
#4CA64C	SDTM-223	TE	Variable	0	TESTRL (trial element start rule) must be present as a variable in the TE dataset.
#4CA64C	SDTM-224	TV	Record	0	TVSTRL (trial visit start rule) must not be null in the TV dataset.
#4CA64C	SDTM-225	TV	Variable	0	VISITNUM must be a numeric variable in TV.
#4CA64C	SDTM-226	TA	Variable	0	TAETORD (order of element within arm) must be a numeric variable in TA.
#4CA64C	SDTM-227	TA	Record	0	ETCD (element code) must not be null in the TA dataset.
#4CA64C	SDTM-228	IE	Record	0	DOMAIN column value must equal 'IE' in the IE dataset.
#4CA64C	SDTM-229	SV	Record	0	DOMAIN column value must equal 'SV' in the SV dataset.
#4CA64C	SDTM-230	PE	Record	0	DOMAIN column value must equal 'PE' in the PE dataset.
#4CA64C	SDTM-231	TS	Record	0	DOMAIN column value must equal 'TS' in the TS dataset.
#4CA64C	SDTM-232	TE	Record	0	DOMAIN column value must equal 'TE' in the TE dataset.
#4CA64C	SDTM-233	EG	Variable	0	EG domain must contain required result variables: EGORRES, EGSTRESC, EGSTRESN, EGSTRESU.
#4CA64C	SDTM-234	PE	Variable	0	PE domain must contain required result variables: PESTRESC, PESTRESN.
#4CA64C	SDTM-235	AE	Variable	0	AESTDTC (start date/time of adverse event) must be present as a variable in the AE dataset.
#4CA64C	SDTM-236	EX	Variable	0	EXDOSE (dose per administration) must be present as a variable in the EX dataset.
#4CA64C	SDTM-237	MH	Variable	0	MHSTDTC (start date/time of medical history event) must be present as a variable in the MH dataset.
#4CA64C	SDTM-238	TV	Record	0	DOMAIN column value must equal 'TV' in the TV dataset.
#4CA64C	SDTM-239	TI	Record	0	DOMAIN column value must equal 'TI' in the TI dataset.
#4CA64C	SDTM-240	TI	Variable	0	IEINCLCR (inclusion/exclusion criterion result flag) must be present as a variable in the TI dataset.
#4CA64C	SDTM-241	SUPPDM	Record	0	QNAM must not be null in SUPPDM.
#4CA64C	SDTM-242	SUPPDM	Record	0	QVAL must not be null in SUPPDM.
#4CA64C	SDTM-243	SUPPAE	Record	0	QNAM must not be null in SUPPAE.
#4CA64C	SDTM-244	SUPPAE	Record	0	QVAL must not be null in SUPPAE.
#4CA64C	SDTM-245	SUPPLB	Record	0	QNAM must not be null in SUPPLB.
#4CA64C	SDTM-246	SUPPDM	Record	0	RDOMAIN in SUPPDM must equal 'DM'.
#4CA64C	SDTM-247	SUPPAE	Record	0	RDOMAIN in SUPPAE must equal 'AE'.
#4CA64C	SDTM-248	SUPPLB	Record	0	RDOMAIN in SUPPLB must equal 'LB'.
#4CA64C	SDTM-249	SUPPVS	Record	0	RDOMAIN in SUPPVS must equal 'VS'.
#4CA64C	SDTM-250	SUPPVS	Record	0	QNAM must not be null in SUPPVS.
#4CA64C	SDTM-251	AE	Record	0	AESTDTC in AE must conform to ISO 8601 format when present.
#4CA64C	SDTM-255	EX	Record	0	EXSTDTC in EX must conform to ISO 8601 format when present.
#4CA64C	SDTM-258	MH	Record	0	MHENDTC in MH must conform to ISO 8601 format when present.
#4CA64C	SDTM-259	DS	Record	0	DSSTDTC in DS must conform to ISO 8601 format when present.
#4CA64C	SDTM-261	VS	Record	0	VSTESTCD (test short name) must not be null in VS.
#4CA64C	SDTM-262	LB	Record	0	LBTESTCD (test short name) must not be null in LB.
#4CA64C	SDTM-263	EG	Record	0	EGTESTCD (test short name) must not be null in EG.
#4CA64C	SDTM-264	VS	Record	0	VSTEST (test name) must not be null in VS.
#4CA64C	SDTM-265	LB	Record	0	LBTEST (test name) must not be null in LB.
#4CA64C	SDTM-266	VS	Record	0	VSORRES (original result) must not be null in VS.
#4CA64C	SDTM-267	LB	Record	0	LBORRES (original result) must not be null in LB.
#4CA64C	SDTM-268	EG	Record	0	EGORRES (original result) must not be null in EG.
#4CA64C	SDTM-269	PE	Record	0	PEORRES (original result) must not be null in PE.
#4CA64C	SDTM-270	LB	Variable	0	VISITNUM must be a numeric variable in LB.
#4CA64C	SDTM-271	AE	Record	0	AESEQ (sequence number) must not be null in AE.
#4CA64C	SDTM-272	CM	Record	0	CMSEQ (sequence number) must not be null in CM.
#4CA64C	SDTM-273	EX	Record	0	EXSEQ (sequence number) must not be null in EX.
#4CA64C	SDTM-274	MH	Record	0	MHSEQ (sequence number) must not be null in MH.
#4CA64C	SDTM-275	VS	Record	0	VSSEQ (sequence number) must not be null in VS.
#4CA64C	SDTM-276	LB	Record	0	LBSEQ (sequence number) must not be null in LB.
#4CA64C	SDTM-277	EG	Record	0	EGSEQ (sequence number) must not be null in EG.
#4CA64C	SDTM-278	PE	Record	0	PESEQ (sequence number) must not be null in PE.
#4CA64C	SDTM-279	DS	Record	0	DSSEQ (sequence number) must not be null in DS.
#4CA64C	SDTM-280	IE	Record	0	IESEQ (sequence number) must not be null in IE.
#4CA64C	SDTM-281	LB	Variable	0	LBSTNRLO (lower limit of reference range) must be a numeric variable in LB.
#4CA64C	SDTM-282	LB	Variable	0	LBSTNRHI (upper limit of reference range) must be a numeric variable in LB.
#4CA64C	SDTM-283	VS	Variable	0	VSSTRESN (numeric result in standard units) must be a numeric variable in VS.
#4CA64C	SDTM-285	VS	Record	0	VSNRIND (reference range indicator) must use values from the NRIND controlled terminology codelist when present in VS.
#4CA64C	SDTM-286	EG	Record	0	EGNRIND (reference range indicator) must use values from the NRIND controlled terminology codelist when present in EG.
#4CA64C	SDTM-287	PE	Record	0	PENRIND (reference range indicator) must use values from the NRIND controlled terminology codelist when present in PE.
#4CA64C	SDTM-288	EG	Variable	0	VISITNUM must be a numeric variable in EG.
#4CA64C	SDTM-289	AE	Variable	0	AESER (serious event flag) must be present in the AE dataset.
#4CA64C	SDTM-290	AE	Variable	0	AESEQ must be a numeric variable in AE.
#4CA64C	SDTM-291	VS	Variable	0	VSSEQ must be a numeric variable in VS.
#4CA64C	SDTM-292	LB	Variable	0	LBSEQ must be a numeric variable in LB.
#4CA64C	SDTM-293	EG	Variable	0	EGSEQ must be a numeric variable in EG.
#4CA64C	SDTM-294	CM	Variable	0	CMSEQ must be a numeric variable in CM.
#4CA64C	SDTM-295	DS	Variable	0	DSSEQ must be a numeric variable in DS.
#4CA64C	SDTM-296	EX	Variable	0	EXSEQ must be a numeric variable in EX.
#4CA64C	SDTM-297	SV	Variable	0	SVSEQ must be a numeric variable in SV.
#4CA64C	SDTM-298	MH	Variable	0	MHSEQ must be a numeric variable in MH.
#4CA64C	SDTM-299	SUPPVS	Record	0	QVAL must not be null in SUPPVS.
#4CA64C	SDTM-300	PE	Record	0	PETEST (physical exam test name) must not be null in PE.
#4CA64C	SDTM-301	AE	Record	0	AETERM (verbatim adverse event term) must not be null in AE.
#4CA64C	SDTM-302	AE	Record	0	AEDECOD (dictionary-derived preferred term) must not be null in AE.
#4CA64C	SDTM-303	AE	Record	0	AEBODSYS (body system or organ class) must not be null in AE.
#4CA64C	SDTM-304	CM	Record	0	CMTRT (verbatim medication name) must not be null in CM.
#4CA64C	SDTM-305	CM	Record	0	CMDECOD (standardized medication name) must not be null in CM.
#4CA64C	SDTM-306	DS	Record	0	DSTERM (verbatim disposition term) must not be null in DS.
#4CA64C	SDTM-307	DS	Record	0	DSDECOD (dictionary-derived disposition term) must not be null in DS.
#4CA64C	SDTM-308	MH	Record	0	MHTERM (verbatim medical history term) must not be null in MH.
#4CA64C	SDTM-309	EX	Record	0	EXTRT (treatment name administered) must not be null in EX.
#4CA64C	SDTM-310	EX	Record	0	EXDOSE (dose per administration) must not be null in EX.
#4CA64C	SDTM-311	VS	Record	0	VSSTRESC (standardized result in character format) must not be null in VS.
#4CA64C	SDTM-312	LB	Record	0	LBSTRESC (standardized result in character format) must not be null in LB.
#4CA64C	SDTM-313	EG	Record	0	EGSTRESC (standardized result in character format) must not be null in EG.
#4CA64C	SDTM-314	PE	Record	0	PESTRESC (standardized result in character format) must not be null in PE.
#4CA64C	SDTM-315	VS	Variable	0	VSSTRESU column must be present in VS.
#4CA64C	SDTM-316	LB	Variable	0	LBSTRESU column must be present in LB.
#4CA64C	SDTM-317	EG	Variable	0	EGSTRESU column must be present in EG.
#4CA64C	SDTM-318	LB	Variable	0	LBSTRESN must be numeric type in LB.
#4CA64C	SDTM-319	EG	Variable	0	EGSTRESN must be numeric type in EG.
#4CA64C	SDTM-320	EX	Variable	0	EXDOSE must be numeric type in EX.
#4CA64C	SDTM-321	TA	Record	0	ARM (arm name) must not be null in TA.
#4CA64C	SDTM-322	TA	Record	0	EPOCH (epoch name) must not be null in TA.
#4CA64C	SDTM-323	TA	Record	0	ELEMENT (trial element name) must not be null in TA.
#4CA64C	SDTM-324	TE	Record	0	TEENRL (trial element end rule) must not be null in TE.
#4CA64C	SDTM-325	TV	Record	0	VISIT (visit description) must not be null in TV.
#4CA64C	SDTM-326	TV	Record	0	ARM (arm name) must not be null in TV.
#4CA64C	SDTM-327	TV	Record	0	ARMCD (arm code) must not be null in TV.
#4CA64C	SDTM-328	TI	Record	0	IETEST (inclusion/exclusion criterion name) must not be null in TI.
#4CA64C	SDTM-329	TI	Record	0	IETESTCD (criterion short name) must not be null in TI.
#4CA64C	SDTM-330	TS	Record	0	TSPARMCD (trial summary parameter short name) must not be null in TS.
#4CA64C	SDTM-331	SV	Record	0	VISITNUM must not be null in SV.
#4CA64C	SDTM-332	SV	Record	0	VISIT must not be null in SV.
#4CA64C	SDTM-333	SV	Record	0	SVSTDTC must conform to ISO 8601 date/time format when present in SV.
#4CA64C	SDTM-334	SV	Record	0	SVENDTC must conform to ISO 8601 date/time format when present in SV.
#4CA64C	SDTM-335	VS	Record	0	VISITNUM must not be null in VS.
#4CA64C	SDTM-336	LB	Record	0	VISITNUM must not be null in LB.
#4CA64C	SDTM-337	EG	Record	0	VISITNUM must not be null in EG.
#4CA64C	SDTM-338	PE	Record	0	VISITNUM must not be null in PE.
#4CA64C	SDTM-339	VS	Variable	0	VISITNUM must be numeric type in VS.
#4CA64C	SDTM-340	PE	Variable	0	VISITNUM must be numeric type in PE.
#4CA64C	SDTM-341	SUPPDM	Record	0	QLABEL must not be null in SUPPDM.
#4CA64C	SDTM-342	SUPPAE	Record	0	QLABEL must not be null in SUPPAE.
#4CA64C	SDTM-343	SUPPLB	Record	0	QLABEL must not be null in SUPPLB.
#4CA64C	SDTM-344	SUPPEG	Record	0	QNAM must not be null in SUPPEG.
#4CA64C	SDTM-345	SUPPEG	Record	0	QVAL must not be null in SUPPEG.
#4CA64C	SDTM-346	SUPPEG	Record	0	RDOMAIN must equal 'EG' in the SUPPEG dataset.
#4CA64C	SDTM-347	SUPPCM	Record	0	QNAM must not be null in SUPPCM.
#4CA64C	SDTM-348	SUPPCM	Record	0	RDOMAIN must equal 'CM' in the SUPPCM dataset.
#4CA64C	SDTM-349	SUPPDS	Record	0	QNAM must not be null in SUPPDS.
#4CA64C	SDTM-350	SUPPDS	Record	0	RDOMAIN must equal 'DS' in the SUPPDS dataset.
#4CA64C	SDTM-351	SUPPMH	Record	0	QNAM must not be null in SUPPMH.
#4CA64C	SDTM-352	SUPPMH	Record	0	RDOMAIN must equal 'MH' in the SUPPMH dataset.
#4CA64C	SDTM-353	AE	Variable	0	AESTDY (AE start study day) must be numeric type in AE.
#4CA64C	SDTM-354	AE	Variable	0	AEENDY (AE end study day) must be numeric type in AE.
#4CA64C	SDTM-355	CM	Variable	0	CMSTDY (CM start study day) must be numeric type in CM.
#4CA64C	SDTM-356	EX	Variable	0	EXSTDY (EX start study day) must be numeric type in EX.
#4CA64C	SDTM-357	MH	Variable	0	MHSTDY (MH start study day) must be numeric type in MH.
#4CA64C	SDTM-358	VS	Variable	0	VSSTDY (VS study day) must be numeric type in VS.
#4CA64C	SDTM-359	LB	Variable	0	LBSTDY (LB study day) must be numeric type in LB.
#4CA64C	SDTM-360	EG	Variable	0	EGSTDY (EG study day) must be numeric type in EG.
#4CA64C	SDTM-361	VS	Record	0	VSDTC in VS must conform to ISO 8601 format when present.
#4CA64C	SDTM-362	LB	Record	0	LBDTC in LB must conform to ISO 8601 format when present.
#4CA64C	SDTM-363	EG	Record	0	EGDTC in EG must conform to ISO 8601 format when present.
#4CA64C	SDTM-364	PE	Record	0	PEDTC in PE must conform to ISO 8601 format when present.
#4CA64C	SDTM-365	AE	Record	0	AEDTC in AE must conform to ISO 8601 format when present.
#4CA64C	SDTM-366	DM	Record	0	BRTHDTC in DM must conform to ISO 8601 format when present.
#4CA64C	SDTM-368	EX	Variable	0	EXENDY in EX must be a numeric type variable.
#4CA64C	SDTM-369	CM	Variable	0	CMENDY in CM must be a numeric type variable.
#4CA64C	SDTM-370	MH	Variable	0	MHENDY in MH must be a numeric type variable.
#4CA64C	SDTM-371	LB	Variable	0	LBSPEC (specimen type) column must be present in the LB domain.
#4CA64C	SDTM-372	CM	Variable	0	CMROUTE (route of administration) column must be present in the CM domain.
#4CA64C	SDTM-373	EX	Variable	0	EXROUTE (route of administration) column must be present in the EX domain.
#4CA64C	SDTM-374	EX	Variable	0	EXDOSFRM (dose form) column must be present in the EX domain.
#4CA64C	SDTM-375	LB	Record	0	LBSPEC must not be null in LB; specimen type is required for each lab result record.
#4CA64C	SDTM-376	AE	Record	0	AESER must not be null in AE; the serious adverse event flag is required for each AE record.
#4CA64C	SDTM-377	VS	Variable	0	VSDY in VS must be a numeric type variable.
#4CA64C	SDTM-378	LB	Variable	0	LBDY in LB must be a numeric type variable.
#4CA64C	SDTM-379	EG	Variable	0	EGDY in EG must be a numeric type variable.
#4CA64C	SDTM-380	PE	Variable	0	PEDY in PE must be a numeric type variable.
#4CA64C	SDTM-381	SUPPVS	Record	0	QLABEL must not be null in SUPPVS; the qualifier label is required in all supplemental datasets.
#4CA64C	SDTM-382	SUPPEG	Record	0	QLABEL must not be null in SUPPEG; the qualifier label is required in all supplemental datasets.
#4CA64C	SDTM-383	SUPPCM	Record	0	QLABEL must not be null in SUPPCM; the qualifier label is required in all supplemental datasets.
#4CA64C	SDTM-384	SUPPDS	Record	0	QLABEL must not be null in SUPPDS; the qualifier label is required in all supplemental datasets.
#4CA64C	SDTM-385	SUPPMH	Record	0	QLABEL must not be null in SUPPMH; the qualifier label is required in all supplemental datasets.
#4CA64C	SDTM-386	SUPPDM	Record	0	IDVAR must not be null in SUPPDM; the linking variable name is required to connect supplemental records to the parent dataset.
#4CA64C	SDTM-387	SUPPDM	Record	0	IDVARVAL must not be null in SUPPDM; the linking variable value is required to connect supplemental records to the parent dataset.
#4CA64C	SDTM-388	SUPPAE	Record	0	IDVAR must not be null in SUPPAE; the linking variable name is required to connect supplemental records to the parent AE dataset.
#4CA64C	SDTM-389	SUPPAE	Record	0	IDVARVAL must not be null in SUPPAE; the linking variable value is required to connect supplemental records to the parent AE dataset.
#4CA64C	SDTM-390	SUPPLB	Record	0	IDVAR must not be null in SUPPLB; the linking variable name is required to connect supplemental records to the parent LB dataset.
#4CA64C	SDTM-391	SUPPLB	Record	0	IDVARVAL must not be null in SUPPLB; the linking variable value is required to connect supplemental records to the parent LB dataset.
#4CA64C	SDTM-392	SUPPVS	Record	0	IDVAR must not be null in SUPPVS; the linking variable name is required to connect supplemental records to the parent VS dataset.
#4CA64C	SDTM-393	SUPPVS	Record	0	IDVARVAL must not be null in SUPPVS; the linking variable value is required to connect supplemental records to the parent VS dataset.
#4CA64C	SDTM-394	TS	Record	0	TSPARM must not be null in TS; the parameter name is required for every trial summary record.
#4CA64C	SDTM-395	TI	Record	0	IECAT must not be null in TI; the inclusion/exclusion category is required for each criterion record.
#4CA64C	SDTM-396	TA	Record	0	ARMCD must not be null in TA; the arm code is required for every trial arm record.
#4CA64C	SDTM-397	TA	Record	0	TAETORD must not be null in TA; the planned element order within the arm is required.
#4CA64C	SDTM-398	TV	Record	0	TVSEQ must not be null in TV; the sequence number is required for every trial visit record.
#4CA64C	SDTM-399	TV	Variable	0	TVSEQ in TV must be a numeric type variable.
#4CA64C	SDTM-400	TI	Record	0	TISEQ must not be null in TI; the sequence number is required for every trial inclusion/exclusion criteria record.
#4CA64C	SDTM-401	TI	Variable	0	TISEQ in TI must be a numeric type variable.
#4CA64C	SDTM-402	TA	Record	0	TASEQ must not be null in TA; the sequence number is required for every trial arm record.
#4CA64C	SDTM-403	TA	Variable	0	TASEQ in TA must be a numeric type variable.
#4CA64C	SDTM-404	TE	Record	0	TESEQ must not be null in TE; the sequence number is required for every trial element record.
#4CA64C	SDTM-405	TE	Variable	0	TESEQ in TE must be a numeric type variable.
#4CA64C	SDTM-406	SV	Record	0	SVSEQ must not be null in SV; the sequence number is required for every subject visit record.
#4CA64C	SDTM-407	PE	Variable	0	PESEQ in PE must be a numeric type variable.
#4CA64C	SDTM-408	IE	Variable	0	IESEQ in IE must be a numeric type variable.
#4CA64C	SDTM-409	PE	Variable	0	PEENDY in PE must be a numeric type variable.
#4CA64C	SDTM-410	IE	Variable	0	IESTDY in IE must be a numeric type variable.
#4CA64C	SDTM-411	IE	Variable	0	IEENDY in IE must be a numeric type variable.
#4CA64C	SDTM-412	DS	Variable	0	DSENDY in DS must be a numeric type variable.
#4CA64C	SDTM-413	EX	Record	0	EXDOSFRM must not be null in EX; the dose form is required for each exposure record.
#4CA64C	SDTM-414	EX	Record	0	EXROUTE must not be null in EX; the route of administration is required for each exposure record.
#4CA64C	SDTM-415	CM	Record	0	CMROUTE must not be null in CM; the route of administration is required for each concomitant medication record.
#4CA64C	SDTM-416	AE	Record	0	AEACN must not be null in AE; the action taken with study treatment is required for each adverse event record.
#4CA64C	SDTM-417	AE	Record	0	AESTDTC must not be null in AE; the adverse event start date/time is required.
#4CA64C	SDTM-418	DS	Record	0	DSSTDTC must not be null in DS; the disposition date/time is required for each disposition record.
#4CA64C	SDTM-419	EX	Record	0	EXSTDTC must not be null in EX; the exposure start date/time is required for each exposure record.
#4CA64C	SDTM-420	SV	Record	0	SVSTDTC must not be null in SV; the subject visit start date/time is required for each subject visit record.
#4CA64C	SDTM-421	SUPPDM	Record	0	DOMAIN must equal 'SUPPDM' in the SUPPDM dataset; each record must carry the correct supplemental qualifier domain code.
#4CA64C	SDTM-422	SUPPAE	Record	0	DOMAIN must equal 'SUPPAE' in the SUPPAE dataset; each record must carry the correct supplemental qualifier domain code.
#4CA64C	SDTM-423	SUPPLB	Record	0	DOMAIN must equal 'SUPPLB' in the SUPPLB dataset; each record must carry the correct supplemental qualifier domain code.
#4CA64C	SDTM-424	SUPPVS	Record	0	DOMAIN must equal 'SUPPVS' in the SUPPVS dataset; each record must carry the correct supplemental qualifier domain code.
#4CA64C	SDTM-425	SUPPEG	Record	0	DOMAIN must equal 'SUPPEG' in the SUPPEG dataset; each record must carry the correct supplemental qualifier domain code.
#4CA64C	SDTM-426	SUPPCM	Record	0	DOMAIN must equal 'SUPPCM' in the SUPPCM dataset; each record must carry the correct supplemental qualifier domain code.
#4CA64C	SDTM-427	SUPPDS	Record	0	DOMAIN must equal 'SUPPDS' in the SUPPDS dataset; each record must carry the correct supplemental qualifier domain code.
#4CA64C	SDTM-428	SUPPMH	Record	0	DOMAIN must equal 'SUPPMH' in the SUPPMH dataset; each record must carry the correct supplemental qualifier domain code.
#4CA64C	SDTM-429	SUPPEG	Record	0	IDVAR must not be null in SUPPEG; the identifier variable name is required to link each supplemental qualifier record back to its parent EG record.
#4CA64C	SDTM-430	SUPPEG	Record	0	IDVARVAL must not be null in SUPPEG; the identifier variable value is required to link each supplemental qualifier record back to its parent EG record.
#4CA64C	SDTM-432	EX	Record	0	EXROUTE in EX must be a valid ROUTE codelist term when present.
#4CA64C	SDTM-433	EX	Record	0	EXDOSFRM in EX must be a valid FRM codelist term when present.
#4CA64C	SDTM-434	TA	Record	0	EPOCH in TA must be a valid EPOCH codelist term when present.
#4CA64C	SDTM-435	EX	Record	0	EXDOSFRQ in EX must be a valid FREQ codelist term when present (dosing frequency per interval).
#AAAAAA	SDTM-049	DEFINE	Variable	0	Variable labels in the submission must match the labels specified in Define-XML.
#AAAAAA	SDTM-050	DEFINE	Variable	0	Variable data types in the submission must match the types declared in Define-XML.
#AAAAAA	SDTM-051	DEFINE	Define	0	Each variable in the DM dataset must be declared in Define-XML.
#AAAAAA	SDTM-052	DEFINE	Define	0	Each variable in the AE dataset must be declared in Define-XML.
#AAAAAA	SDTM-053	DEFINE	Define	0	Variables declared Mandatory in Define-XML must not contain null values in DM.
#AAAAAA	SDTM-054	DEFINE	Define	0	Variables declared Mandatory in Define-XML must not contain null values in AE.
#AAAAAA	SDTM-055	DEFINE	Define	0	Variable data types in DM must match the types declared in Define-XML.
#AAAAAA	SDTM-056	DEFINE	Codelist	0	SEX values in DM must be from the codelist declared in Define-XML.
#AAAAAA	SDTM-057	DEFINE	Codelist	0	RACE values in DM must be from the codelist declared in Define-XML.
#AAAAAA	SDTM-058	DEFINE	Codelist	0	ETHNIC values in DM must be from the codelist declared in Define-XML.
#AAAAAA	SDTM-059	DEFINE	Codelist	0	AESEV values in AE must be from the codelist declared in Define-XML.
#AAAAAA	SDTM-060	DEFINE	Codelist	0	AEOUT values in AE must be from the codelist declared in Define-XML.
CT: sdtm-ct-2024-09-27

Domain keys are matched case-insensitively ("dm" and "DM" are equivalent). Polars, pandas, and any other narwhals-compatible DataFrame are accepted. The report object itself renders the tabular summary in a notebook; read on to learn how to drill into failures and access findings programmatically.

The Conformance Report

The tabular report shown above is produced by get_tabular_report(). Each row is one rule from the SDTMIG 3.4 catalog; the colored bar on the left edge encodes its status:

Color	Status	Meaning
Green	pass	The rule was evaluated and no violations were found
Red	fail	One or more records or datasets violated the rule
Amber	error	The rule could not be evaluated (unexpected data state)
Grey	not_applicable	The rule requires a dataset or variable that was not supplied
Grey	not_supported	The rule type is not yet implemented in the built-in engine

Rules are sorted by severity: failures first, then errors, then passes, then not-applicable.

The header shows a PASS or FAIL badge alongside the standard, version, and a full status breakdown (e.g., SDTMIG 3-4 · 410 passed · 4 failed · 12 n/a).

Call get_tabular_report() to get the GT object directly if you need to embed it in a report pipeline:

gt = report.get_tabular_report()
gt

The GT object can be passed to any Great Tables export method (for example, gt.as_raw_html() to embed the table in a custom HTML report, or gt.gtsave("report.png") to render it as an image). When failures are present, use the findings surfaces below to investigate the specific records that triggered each rule.

Findings Drill-Down

When rules fail, the tabular report shows how many records violated each rule but not which ones. get_findings_table() provides that drill-down: one row per failing record, showing the subject, the specific column that violated the rule, the offending value, and the 1-based row number in the source dataset.

To see it in action, introduce a few deliberate violations:

dm_with_issues = pl.DataFrame({
    "STUDYID": ["STUDY01"] * 4,
    "DOMAIN":  ["DM"] * 4,
    "USUBJID": ["STUDY01-01-001", "STUDY01-01-002", "STUDY01-01-003", "STUDY01-01-004"],
    "SUBJID":  ["001", "002", "003", "004"],
    "RFSTDTC": ["2024-01-15", "2024-01-16", "2024-01-17", "2024-01-18"],
    "SEX":     ["M", "F", "UNKNOWN", "F"],      # "UNKNOWN" is not in the SEX codelist
    "RACE":    ["WHITE", "ASIAN", "WHITE", "BLACK OR AFRICAN AMERICAN"],
    "ETHNIC":  ["NOT HISPANIC OR LATINO"] * 4,
    "ARMCD":   ["TRT", "PBO", "TRT", "PBO"],
    "ARM":     ["Treatment", "Placebo", "Treatment", "Placebo"],
    "COUNTRY": ["USA"] * 4,
    "AGE":     [45, -5, 38, 55],               # -5 violates AGE >= 0
    "AGEU":    ["YEARS"] * 4,
    "DMDTC":   ["2024-01-10", "not-a-date", "2024-01-10", "2024-01-10"],  # invalid ISO date
    "DMDY":    [1] * 4,
    "SITEID":  ["01"] * 4,
})

report_with_issues = pb.validate_sdtmig({"DM": dm_with_issues})
report_with_issues.get_findings_table()

/opt/hostedtoolcache/Python/3.11.15/x64/lib/python3.11/site-packages/great_tables/_render_checks.py:37: RenderWarning: Rendering table with .cols_width() in Quarto may result in unexpected behavior. This is because Quarto performs custom table processing. Either use all percentage widths, or set .tab_options(quarto_disable_processing=True) to disable Quarto table processing.
  warnings.warn(

Findings Report for CDISC Conformance
SDTMIG 3-4 · 7 failed (407 passed) · 12 n/a
	SDTM Rule Definition			Finding
	Rule	Domain	Description	USUBJID	Column	Row	Value
#FF3300	SDTM-007	DM	SEX in DM must use values from the CDISC controlled terminology codelist SEX.	STUDY01-01-003	SEX	3	UNKNOWN
#FF3300	SDTM-010	DM	DMDTC in DM must be in ISO 8601 extended datetime format.	STUDY01-01-002	DMDTC	2	not-a-date
#FF3300	SDTM-195	DM	AGE must not be negative in the DM dataset.	STUDY01-01-002	AGE	2	-5

The findings table groups its columns into two spanners:

• Rule: Domain and Description identify which rule fired and where.
• Finding: USUBJID identifies the subject; Column and Value show exactly what was wrong; Row is the 1-based row number in the source dataset for quick lookup.

At most 100 findings per rule are shown in the table. The true total for each rule is always visible in get_tabular_report(). To export findings to a spreadsheet or join them back to your source data, use findings_df() instead.

Programmatic Access with findings_df()

findings_df() returns the same findings as a Polars DataFrame, which is better suited for filtering, grouping, exporting to CSV, or joining back to the source data:

df = report_with_issues.findings_df()
df

shape: (3, 7)

rule_id	dataset	row_index	usubjid	checked_column	checked_value	description
str	str	i64	str	str	str	str
"SDTM-007"	"DM"	2	"STUDY01-01-003"	"SEX"	"UNKNOWN"	"SEX in DM must use values from…
"SDTM-010"	"DM"	1	"STUDY01-01-002"	"DMDTC"	"not-a-date"	"DMDTC in DM must be in ISO 860…
"SDTM-195"	"DM"	1	"STUDY01-01-002"	"AGE"	"-5"	"AGE must not be negative in th…

The DataFrame schema is:

Column	Description
rule_id	CDISC CORE rule identifier (e.g., "SDTM-007")
dataset	SDTM domain the failing record belongs to
row_index	0-based row position in the source dataset
usubjid	Unique Subject Identifier (USUBJID) for the failing record
checked_column	The variable that violated the rule (e.g., "SEX")
checked_value	The actual value found in checked_column
description	Human-readable rule description

import polars as pl

# Filter to a specific rule
df.filter(pl.col("rule_id") == "SDTM-007")

shape: (1, 7)

rule_id	dataset	row_index	usubjid	checked_column	checked_value	description
str	str	i64	str	str	str	str
"SDTM-007"	"DM"	2	"STUDY01-01-003"	"SEX"	"UNKNOWN"	"SEX in DM must use values from…

# Group by rule to count violations
df.group_by("rule_id").agg(pl.len().alias("n_violations")).sort("n_violations", descending=True)

shape: (3, 2)

rule_id	n_violations
str	u32
"SDTM-007"	1
"SDTM-010"	1
"SDTM-195"	1

The DataFrame is empty (with the same schema) when all rules pass, so it is safe to call unconditionally in a script. Use it to triage failures before running the more time-intensive CDISC CORE engine, or to generate a custom summary report tailored to your team’s workflow.

What the Rule Catalog Covers

The bundled SDTMIG 3.4 catalog contains 426 rules across seven types:

Type	Description	Examples
RECORD_CHECK	Per-row value checks	Codelist membership, ISO 8601 dates, numeric ranges
VARIABLE_METADATA_CHECK	Variable presence and column ordering	USUBJID must precede domain-specific variables
DATASET_METADATA_CHECK	Dataset-level attributes	Required sort key order
DATASET_CONTENTS_CHECK	Dataset-level value constraints	All rows in a domain must share the same STUDYID
DOMAIN_PRESENCE_CHECK	Required or prohibited domain presence	DM must be present
DEFINE_ITEM_METADATA_CHECK	Variable declarations against Define-XML	Activated when define_xml is supplied
DEFINE_CODELIST_CHECK	Codelist values against Define-XML	Activated when define_xml is supplied

Only RECORD_CHECK and DATASET_CONTENTS_CHECK rules produce row-level findings accessible via findings_df() and get_findings_table(). The other types report a violation count in get_tabular_report() but do not have individual record detail.

Rules that require a domain or variable not present in your datasets are automatically marked not_applicable (they are not counted as failures). For example, a rule that checks AESTDTC in the AE domain is not_applicable when no AE dataset is supplied. Adding more domains to the dictionary passed to validate_sdtmig() will convert more rules from not_applicable to executable, giving a more complete conformance picture.

Controlled Terminology

Codelist checks use the bundled CT package sdtm-ct-2024-09-27. Two important behaviors:

• Case-insensitive matching: a value of "beats/min" matches the codelist term "BEATS/MIN". This avoids false positives for studies that applied mixed-case CT values.
• SAS/XPT empty strings treated as null: SAS Transport files encode character missing values as "" (empty string) rather than None. The engine recognizes this and skips codelist and format checks for such cells, preventing the large volumes of false positives that occur with a naive string comparison.

Both behaviors apply automatically with no configuration. If you need to pin a different CT version or supply additional packages, see the next section.

Supply a Custom CT Package

By default the most recent bundled CT package is used. Pass ct_packages to pin a specific version or supply additional packages:

report = pb.validate_sdtmig(
    {"DM": dm},
    ct_packages=["sdtm-ct-2024-09-27"],
)

Pinning the CT version is useful when your study was locked against a specific CDISC CT release and you want the conformance check to reflect that snapshot rather than the latest terms.

Activating Define-XML Rules

Pass a path to define.xml to activate the Define-XML-aware rule types:

report = pb.validate_sdtmig(
    {"DM": dm, "AE": ae},
    define_xml="path/to/define.xml",
)

Without define_xml, the 76 DEFINE_ITEM_METADATA_CHECK and DEFINE_CODELIST_CHECK rules are marked not_applicable. Supplying the file allows the engine to verify that every variable present in your datasets is declared in Define-XML with the correct type and, where applicable, a valid codelist.

Loading XPT Files

For datasets stored as SAS Transport (XPT) files, use pyreadstat to load them before passing to validate_sdtmig(). Install it with pip install pyreadstat:

import pyreadstat
import polars as pl
import pointblank as pb

def load_xpt(path: str) -> pl.DataFrame:
    df, _ = pyreadstat.read_xport(path)
    return pl.from_pandas(df)

report = pb.validate_sdtmig(
    {
        "DM": load_xpt("sdtm/dm.xpt"),
        "AE": load_xpt("sdtm/ae.xpt"),
        "LB": load_xpt("sdtm/lb.xpt"),
        "VS": load_xpt("sdtm/vs.xpt"),
    },
    study_id="STUDY01",
)

Pointblank handles the SAS empty-string convention automatically, so XPT data does not require any preprocessing before being passed to validate_sdtmig(). The same built-in handling applies whether data arrives from XPT files, in-memory DataFrames, or any other narwhals-compatible source.

Prerequisites

validate_sdtmig() and the ConformanceReport methods require no additional dependencies beyond Pointblank itself. The optional extras are:

• Reading XPT files with pyreadstat: pip install pyreadstat
• Writing XPT files for CORE (automatic, handled internally): pip install pyreadstat
• Excel export with to_excel(): pip install openpyxl

pip install pointblank[cdisc]    # adds pyreadstat
pip install pointblank[excel]    # adds openpyxl

The CDISC CORE engine is not a Python dependency of Pointblank and must be installed separately when needed. See Installing the CDISC CORE Engine below.

CDISC CORE Engine (Advanced)

The CDISC CORE engine runs the full authoritative conformance rule set and produces reports accepted by FDA and PMDA review tools. Use it as the final pre-submission gate after the built-in engine gives a clean result.

Installing the CDISC CORE Engine

CORE can be obtained in three ways depending on your environment. The standalone executable is easiest for local use, Docker is preferred in containerized CI pipelines, and the repo checkout is useful when you need a specific unreleased version or want to inspect the rule definitions directly.

Option 1: Standalone executable. Download the pre-built binary from the CDISC CORE releases page. Place it somewhere on your PATH under the name core:

chmod +x core
sudo mv core /usr/local/bin/
core --version

Once the binary is on PATH, Pointblank will discover it automatically with no additional configuration required.

Option 2: Docker. CDISC publishes an official Docker image that includes the engine and its full rules cache:

docker pull cdisc/cdisc-rules-engine:latest

docker run --rm \
    -v /path/to/study/data:/data \
    cdisc/cdisc-rules-engine:latest \
    validate -s sdtmig -v 3-4 -d /data -of JSON -o /data/report

When running via Docker you will typically invoke CORE directly rather than through Pointblank’s subprocess wrapper. The resulting JSON output can be loaded with parse_core_report() and wrapped in a ConformanceReport for further analysis.

Option 3: Repo checkout.

git clone https://github.com/cdisc-org/cdisc-rules-engine.git
cd cdisc-rules-engine
pip install -r requirements.txt
python core.py --version

When using a repo checkout, pass the repo root as core_cwd so Pointblank sets the subprocess working directory correctly.

Telling Pointblank Where to Find CORE

Pointblank discovers CORE through three mechanisms, tried in order:

1. An explicit core= argument to validate_cdisc_submission() or validate_conformance(engine="core").
2. The POINTBLANK_CDISC_CORE environment variable (e.g., export POINTBLANK_CDISC_CORE="python /path/to/core.py").
3. A core or cdisc-rules-engine executable on PATH.

The environment variable approach is convenient for CI systems where the CORE path differs between machines, while the explicit argument is useful in notebooks where you want the path to be self-documenting.

Running CORE

validate_cdisc_submission() is the simplest way to run a CORE validation. It accepts an in-memory dictionary of DataFrames, a folder path, or an existing SubmissionPackage:

report = pb.validate_cdisc_submission(
    {"DM": dm, "AE": ae},
    standard="sdtmig",
    version="3.4",
    agency="FDA",
)

For a folder of XPT files pass the path directly. Pointblank skips the materialization step and passes the folder straight to CORE:

report = pb.validate_cdisc_submission(
    "path/to/sdtm/",
    standard="sdtmig",
    version="3.4",
    agency="FDA",
)

For repo-checkout CORE, pass the command prefix and working directory:

report = pb.validate_cdisc_submission(
    {"DM": dm},
    standard="sdtmig",
    version="3.4",
    core=["python", "/path/to/cdisc-rules-engine/core.py"],
    core_cwd="/path/to/cdisc-rules-engine",
    cache="/path/to/cdisc-rules-engine/resources/cache",
)

In all cases the return value is a ConformanceReport with is_core=True. The sections below describe the accessor methods available on a CORE report.

Working with a CORE ConformanceReport

The examples below use a captured real CORE report so that the code runs without requiring CORE to be installed in the docs environment. The structure is identical to what a live run produces.

import json
from pathlib import Path
from pointblank.metadata import parse_core_report, ConformanceReport

_fixtures = Path(pb.__file__).parent.parent / "tests" / "metadata_fixtures" / "cdisc_core"
raw = json.loads((_fixtures / "core_report_full.json").read_text())

report = ConformanceReport.from_core_report(raw, agency="FDA")
print(report)

ConformanceReport (CORE)
  Agency: FDA
  SDTMIG V3.4 — CORE 0.16.0
  430 rules (EXECUTION ERROR=2, ISSUE REPORTED=6, SKIPPED=344, SUCCESS=78)
  8 issues — FAIL

Overall result. all_passed() returns True when no rules reported issues; is_core confirms the report originated from the CORE engine rather than the built-in engine:

print("All passed:", report.all_passed())
print("Is CORE report:", report.is_core)

All passed: False
Is CORE report: True

Summary dictionary. summary() returns run provenance and rule counts as a plain dictionary, useful for logging, assertions in CI scripts, or building a custom status page:

s = report.summary()

print(f"Standard:        {s['standard']} {s['version']}")
print(f"Engine:          {s['engine_version']}")
print(f"Rules evaluated: {s['n_rules']}")
print(f"Total issues:    {s['n_issues']}")
print()

print("Rule status breakdown:")
for status, count in sorted(s["status_counts"].items()):
    print(f"  {status:20s}: {count}")

Standard:        SDTMIG V3.4
Engine:          0.16.0
Rules evaluated: 430
Total issues:    8

Rule status breakdown:
  EXECUTION ERROR     : 2
  ISSUE REPORTED      : 6
  SKIPPED             : 344
  SUCCESS             : 78

The status_counts dictionary enumerates every status bucket CORE reported. Use it to build pass/fail thresholds or trend charts across multiple submission runs.

Issues. issues() returns one record per (dataset, rule) pair that reported at least one issue. Pass a status filter to separate conformance violations from execution errors:

issues = report.issues()
print(f"Issue entries: {len(issues)}")

for issue in issues[:3]:
    print()
    print(f"  Dataset:  {issue['dataset']}")
    print(f"  Rule:     {issue['rule_id']}")
    print(f"  Message:  {issue['message']}")
    print(f"  Issues:   {issue['issues']}")

Issue entries: 8

  Dataset:  STUDY
  Rule:     CORE-000581
  Message:  DM dataset is missing.
  Issues:   1

  Dataset:  TEST_DATASET
  Rule:     CORE-000357
  Message:  Supplemental qualifier dataset associated with a split dataset is greater than 8 characters in length
  Issues:   1

  Dataset:  TEST_DATASET
  Rule:     CORE-000510
  Message:  Split dataset name is not 3 or 4 characters in length
  Issues:   1

from pointblank.metadata._cdisc_core import STATUS_ISSUE, STATUS_ERROR

reported_issues = report.issues(status=STATUS_ISSUE)
print(f"Rules with issues: {len(reported_issues)}")

exec_errors = report.issues(status=STATUS_ERROR)
print(f"Execution errors:  {len(exec_errors)}")

Rules with issues: 6
Execution errors:  2

Execution errors (STATUS_ERROR) indicate that CORE could not evaluate a rule, typically because a required variable or dataset was absent or had an unexpected format. They are distinct from conformance issues (STATUS_ISSUE) where the rule ran successfully but found a violation.

Row-level findings. findings() returns the row-level detail from CORE’s Issue_Details section, giving the exact record that triggered each rule:

findings = report.findings()
print(f"Row-level findings: {len(findings)}")

f = findings[0]
print()
print(f"Rule:          {f.rule_id}")
print(f"Dataset:       {f.dataset}")
print(f"Row:           {f.row}")
print(f"USUBJID:       {f.usubjid}")
print(f"Variables:     {f.variables}")
print(f"Values:        {f.values}")

Row-level findings: 8

Rule:          CORE-000357
Dataset:       TEST_DATASET
Row:           1
USUBJID:       None
Variables:     ['dataset_name']
Values:        ['TEST_DATASET']

Each finding carries the USUBJID, the affected variables and their values, and the 1-based row number in the source dataset, matching the information shown in the built-in engine’s findings table.

Per-rule run results. rules() returns one CoreRuleResult per rule with its run status:

from pointblank.metadata._cdisc_core import STATUS_SUCCESS, STATUS_SKIPPED

all_rules = report.rules()
print(f"Total rules:  {len(all_rules)}")
print(f"Successful:   {len(report.rules(status=STATUS_SUCCESS))}")
print(f"Skipped:      {len(report.rules(status=STATUS_SKIPPED))}")

failing = [r for r in all_rules if r.is_failing]
print(f"Failing:      {len(failing)}")
for r in failing:
    print(f"  {r.rule_id:15s} [{r.status}]  {(r.message or '')[:60]}")

Total rules:  430
Successful:   78
Skipped:      344
Failing:      8
  CORE-000357     [ISSUE REPORTED]  Supplemental qualifier dataset associated with a split datas
  CORE-000510     [ISSUE REPORTED]  Split dataset name is not 3 or 4 characters in length
  CORE-000539     [ISSUE REPORTED]  Split dataset is present but the two-Letter parent domain is
  CORE-000581     [ISSUE REPORTED]  DM dataset is missing.
  CORE-000598     [ISSUE REPORTED]  Dataset name does not begin with DOMAIN value
  CORE-000778     [ISSUE REPORTED]  Associated Persons non-supplemental qualifier dataset associ
  CORE-000929     [EXECUTION ERROR]  DOMAIN Code is not a published DOMAIN Code in CDISC Controll
  CORE-001081     [EXECUTION ERROR]  Variable role specified in the define-xml does not match the

Rules marked skipped are not failures. CORE skips rules when the dataset or variable they check is absent from the submission. A skipped rule is equivalent to not_applicable in the built-in engine and should not be treated as a conformance problem.

Exporting Reports

Both built-in and CORE reports can be exported for archiving, sharing with a biometrics team, or loading into a review tool. Two formats are supported: JSON for round-trippable machine-readable output, and Excel for spreadsheet-based review workflows.

JSON

to_json() saves the report as a JSON file. For CORE reports the structure mirrors CORE’s native output and is parseable by parse_core_report():

import tempfile

with tempfile.TemporaryDirectory() as tmp:
    dest = report.to_json(Path(tmp) / "conformance_report.json")
    print(f"Written to: {dest.name}")
    print(f"File size:  {dest.stat().st_size:,} bytes")

    reloaded = json.loads(dest.read_text())
    reparsed = parse_core_report(reloaded)
    print(f"Rules after round-trip: {len(reparsed.rules)}")

Written to: conformance_report.json
File size:  113,079 bytes
Rules after round-trip: 430

The round-trip fidelity means a JSON file written by Pointblank can be re-loaded later without re-running CORE, which is useful for archiving the state of a submission at a specific point in time.

Excel

to_excel() writes the report as a workbook. Requires openpyxl:

dest = report.to_excel("conformance_report.xlsx")

For CORE reports the workbook has four sheets: Issue_Summary, Issue_Details, Rules_Report, and Conformance_Details.

Using Both Engines Together

The built-in engine provides fast feedback during development; CORE is the final gate. The typical workflow is to iterate with the built-in engine until it reports a clean result, then run CORE once as a pre-submission check:

# Step 1: fast iteration with the built-in engine
report = pb.validate_sdtmig({"DM": dm, "AE": ae}, study_id="STUDY01")

if not report.all_passed():
    print("Fix rule violations before running CORE:")
    df = report.findings_df()
    print(df.group_by("rule_id").agg(pl.len().alias("n")).sort("n", descending=True))
    raise SystemExit(1)

# Step 2: final gate with CDISC CORE
core_report = pb.validate_cdisc_submission(
    {"DM": dm, "AE": ae},
    standard="sdtmig",
    version="3.4",
    agency="FDA",
)

if not core_report.all_passed():
    failing = [r for r in core_report.rules() if r.is_failing]
    print(f"CORE found {len(failing)} failing rules.")
    core_report.to_json("core_report.json")
    raise SystemExit(1)

print("Submission passed all conformance checks.")

This pattern catches the majority of conformance problems early (when fixing them is cheap) and reserves the slower CORE invocation for the final verification step. Both reports can be exported and archived alongside the submission package.

Running the Integration Tests

Pointblank ships integration tests for the full CORE pipeline. They are skipped automatically when CORE is not discoverable:

# Run when CORE is on PATH:
pytest -m cdisc_core

# With a repo-checkout CORE:
export POINTBLANK_CDISC_CORE="python /path/to/core.py"
export POINTBLANK_CDISC_CORE_CWD="/path/to/cdisc-rules-engine"
pytest -m cdisc_core

The integration tests validate the full subprocess pipeline end-to-end, including XPT materialization, CORE invocation, JSON parsing, and report construction. Running them against your local CORE installation is a good sanity check after upgrading either Pointblank or the CORE engine.