# 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](https://github.com/cdisc-org/cdisc-rules-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: ``` python 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](../../reference/Validate.error.md#pointblank.Validate.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()](../../reference/Validate.get_tabular_report.md#pointblank.Validate.get_tabular_report) to get the `GT` object directly if you need to embed it in a report pipeline: ``` python 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: ``` python 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()](../../reference/Validate.get_tabular_report.md#pointblank.Validate.get_tabular_report). To export findings to a spreadsheet or join them back to your source data, use [findings_df()](../../reference/ConformanceReport.md#pointblank.ConformanceReport.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: ``` python 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 | ``` python 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… | ``` python # 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()](../../reference/ConformanceReport.md#pointblank.ConformanceReport.findings_df) and [get_findings_table()](../../reference/ConformanceReport.md#pointblank.ConformanceReport.get_findings_table). The other types report a violation count in [get_tabular_report()](../../reference/Validate.get_tabular_report.md#pointblank.Validate.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()](../../reference/validate_sdtmig.md#pointblank.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: ``` python 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: ``` python 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()](../../reference/validate_sdtmig.md#pointblank.validate_sdtmig). Install it with `pip install pyreadstat`: ``` python 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()](../../reference/validate_sdtmig.md#pointblank.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()](../../reference/validate_sdtmig.md#pointblank.validate_sdtmig) and the [ConformanceReport](../../reference/ConformanceReport.md#pointblank.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()](../../reference/ConformanceReport.md#pointblank.ConformanceReport.to_excel): `pip install openpyxl` ``` bash 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](#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](https://github.com/cdisc-org/cdisc-rules-engine/releases). Place it somewhere on your `PATH` under the name [core](../../reference/SDTMVariableSpec.md#pointblank.SDTMVariableSpec.core): ``` bash 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: ``` bash 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](../../reference/ConformanceReport.md#pointblank.ConformanceReport) for further analysis. **Option 3: Repo checkout.** ``` bash 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()](../../reference/validate_cdisc_submission.md#pointblank.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](../../reference/SDTMVariableSpec.md#pointblank.SDTMVariableSpec.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()](../../reference/validate_cdisc_submission.md#pointblank.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](../../reference/SubmissionPackage.md#pointblank.SubmissionPackage): ``` python 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: ``` python 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: ``` python 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](../../reference/ConformanceReport.md#pointblank.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. ``` python 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()](../../reference/Validate.all_passed.md#pointblank.Validate.all_passed) returns `True` when no rules reported issues; [is_core](../../reference/ConformanceReport.md#pointblank.ConformanceReport.is_core) confirms the report originated from the CORE engine rather than the built-in engine: ``` python print("All passed:", report.all_passed()) print("Is CORE report:", report.is_core) ``` All passed: False Is CORE report: True **Summary dictionary.** [summary()](../../reference/ContractImport.md#pointblank.ContractImport.summary) returns run provenance and rule counts as a plain dictionary, useful for logging, assertions in CI scripts, or building a custom status page: ``` python 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()](../../reference/ConformanceReport.md#pointblank.ConformanceReport.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: ``` python 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 ``` python 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()](../../reference/ConformanceReport.md#pointblank.ConformanceReport.findings) returns the row-level detail from CORE's `Issue_Details` section, giving the exact record that triggered each rule: ``` python 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()](../../reference/ConformanceReport.md#pointblank.ConformanceReport.rules) returns one `CoreRuleResult` per rule with its run status: ``` python 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()](../../reference/ConformanceReport.md#pointblank.ConformanceReport.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()`: ``` python 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()](../../reference/ConformanceReport.md#pointblank.ConformanceReport.to_excel) writes the report as a workbook. Requires `openpyxl`: ``` python 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: ``` python # 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: ``` bash # 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.