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Initial Rules and Data #2

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c484be4
standards
SFJohnson24 Mar 5, 2026
448e44c
rules
SFJohnson24 Mar 5, 2026
c4b01f5
remove sheet .xpt
SFJohnson24 Mar 6, 2026
0058037
rules and test data sorted
SFJohnson24 Mar 20, 2026
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4 changes: 4 additions & 0 deletions Published/CORE-000001/negative/01/data/ie.csv
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STUDYID,DOMAIN,USUBJID,IESEQ,IETESTCD,IETEST,IECAT,IEORRES,IESTRESC,EPOCH,IEDTC,IEDY
CDISCPILOT01,IE,CDISC015,1,INCL03,Is not pregnant or nursing.,INCLUSION,Y,Y,SCREENING,2014-03-17,
CDISCPILOT01,IE,CDISC016,1,INCL03,Is not pregnant or nursing.,INCLUSION,Yes,Yes,SCREENING,2014-03-17,
CDISCPILOT01,IE,CDISC017,1,INCL03,Is not pregnant or nursing.,INCLUSION,Nope,Nope,SCREENING,2014-03-17,
2 changes: 2 additions & 0 deletions Published/CORE-000001/negative/01/data/tables.csv
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Filename,Label
ie.xpt,Inclusion/Exclusion Criteria Not Met
13 changes: 13 additions & 0 deletions Published/CORE-000001/negative/01/data/variables.csv
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dataset,variable,label,type,length
ie.xpt,STUDYID,Study Identifier,Char,12
ie.xpt,DOMAIN,Domain Abbreviation,Char,2
ie.xpt,USUBJID,Unique Subject Identifier,Char,8
ie.xpt,IESEQ,Sequence Number,Num,8
ie.xpt,IETESTCD,Inclusion/Exclusion Criterion Short Name,Char,7
ie.xpt,IETEST,Inclusion/Exclusion Criterion,Char,196
ie.xpt,IECAT,Inclusion/Exclusion Category,Char,9
ie.xpt,IEORRES,I/E Criterion Original Result,Char,1
ie.xpt,IESTRESC,I/E Criterion Result in Std Format,Char,1
ie.xpt,EPOCH,Epoch,Char,9
ie.xpt,IEDTC,Date/Time of Collection,Char,10
ie.xpt,IEDY,Study Day of Collection,Num,8
288 changes: 288 additions & 0 deletions Published/CORE-000001/negative/01/results/CG0176_negative_request_20250402.json
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{
"rule": {
"Authorities": [
{
"Organization": "CDISC",
"Standards": [
{
"Name": "SDTMIG",
"References": [
{
"Citations": [
{
"Document": "SDTM v3.4",
"Section": "6.3.4",
"Cited_Guidance": "The intent of the domain model is to collect responses to only those criteria that the subject did not meet, and not the responses to all criteria."
}
],
"Origin": "SDTM and SDTMIG Conformance Rules",
"Version": "2.0",
"Rule_Identifier": {
"Id": "CG0176",
"Version": "1"
}
}
],
"Version": "3.4"
},
{
"Name": "SDTMIG",
"References": [
{
"Citations": [
{
"Document": "IG v3.2",
"Item": "Assumption 2",
"Section": "6.3",
"Cited_Guidance": "The intent of the domain model is to collect response to only those criteria that the subject did not meet, and not the responses to all criteria."
}
],
"Origin": "SDTM and SDTMIG Conformance Rules",
"Version": "2.0",
"Rule_Identifier": {
"Id": "CG0176",
"Version": "1"
}
}
],
"Version": "3.2"
},
{
"Name": "SDTMIG",
"References": [
{
"Citations": [
{
"Document": "IG v3.3",
"Item": "Assumption 1",
"Section": "6.3.4",
"Cited_Guidance": "The intent of the domain model is to collect response to only those criteria that the subject did not meet, and not the responses to all criteria."
}
],
"Origin": "SDTM and SDTMIG Conformance Rules",
"Version": "2.0",
"Rule_Identifier": {
"Id": "CG0176",
"Version": "1"
}
}
],
"Version": "3.3"
},
{
"Name": "TIG",
"References": [
{
"Citations": [
{
"Document": "TIG 1.0",
"Item": "Assumption 1",
"Section": "2.8.10.13",
"Cited_Guidance": "The intent of the domain model is to collect responses to only those criteria that the subject did not meet, and not the responses to all criteria."
}
],
"Origin": "TIG Conformance Rules",
"Version": "1.0",
"Rule_Identifier": {
"Id": "TIG0405",
"Version": "1"
}
}
],
"Substandard": "SDTM",
"Version": "1.0"
}
]
}
],
"Check": {
"all": [
{
"name": "IECAT",
"operator": "equal_to",
"value": "INCLUSION",
"value_is_literal": true
},
{
"name": "IEORRES",
"operator": "not_equal_to",
"value": "N",
"value_is_literal": true
}
]
},
"Core": {
"Id": "CORE-000001",
"Status": "Published",
"Version": "1"
},
"Description": "Raise an error when IECAT is equal to 'INCLUSION' and IEORRES is not equal to 'N'.",
"Executability": "Fully Executable",
"Outcome": {
"Message": "IEORRES is not equal to 'N' when IECAT equals 'INCLUSION'."
},
"Scope": {
"Classes": {
"Include": [
"FINDINGS"
]
},
"Domains": {
"Include": [
"IE"
]
},
"Use_Case": "INDH"
},
"Sensitivity": "Record",
"Rule_Type": "Record Data"
},
"datasets": [
{
"filename": "ie.xpt",
"label": "Inclusion/Exclusion Criteria Not Met",
"domain": "IE",
"variables": [
{
"name": "STUDYID",
"label": "Study Identifier",
"type": "Char",
"length": 12
},
{
"name": "DOMAIN",
"label": "Domain Abbreviation",
"type": "Char",
"length": 2
},
{
"name": "USUBJID",
"label": "Unique Subject Identifier",
"type": "Char",
"length": 8
},
{
"name": "IESEQ",
"label": "Sequence Number",
"type": "Num",
"length": 8
},
{
"name": "IETESTCD",
"label": "Inclusion/Exclusion Criterion Short Name",
"type": "Char",
"length": 7
},
{
"name": "IETEST",
"label": "Inclusion/Exclusion Criterion",
"type": "Char",
"length": 196
},
{
"name": "IECAT",
"label": "Inclusion/Exclusion Category",
"type": "Char",
"length": 9
},
{
"name": "IEORRES",
"label": "I/E Criterion Original Result",
"type": "Char",
"length": 1
},
{
"name": "IESTRESC",
"label": "I/E Criterion Result in Std Format",
"type": "Char",
"length": 1
},
{
"name": "EPOCH",
"label": "Epoch",
"type": "Char",
"length": 9
},
{
"name": "IEDTC",
"label": "Date/Time of Collection",
"type": "Char",
"length": 10
},
{
"name": "IEDY",
"label": "Study Day of Collection",
"type": "Num",
"length": 8
}
],
"records": {
"STUDYID": [
"CDISCPILOT01",
"CDISCPILOT01",
"CDISCPILOT01"
],
"DOMAIN": [
"IE",
"IE",
"IE"
],
"USUBJID": [
"CDISC015",
"CDISC016",
"CDISC017"
],
"IESEQ": [
1,
1,
1
],
"IETESTCD": [
"INCL03",
"INCL03",
"INCL03"
],
"IETEST": [
"Is not pregnant or nursing.",
"Is not pregnant or nursing.",
"Is not pregnant or nursing."
],
"IECAT": [
"INCLUSION",
"INCLUSION",
"INCLUSION"
],
"IEORRES": [
"Y",
"Yes",
"Nope"
],
"IESTRESC": [
"Y",
"Yes",
"Nope"
],
"EPOCH": [
"SCREENING",
"SCREENING",
"SCREENING"
],
"IEDTC": [
"2014-03-17",
"2014-03-17",
"2014-03-17"
],
"IEDY": [
null,
null,
null
]
}
}
],
"standard": {
"product": "sdtmig",
"version": "3-3"
},
"codelists": []
}
46 changes: 46 additions & 0 deletions Published/CORE-000001/negative/01/results/CG0176_negative_results_20250402.json
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{
"IE": [
{
"executionStatus": "success",
"dataset": "ie.xpt",
"domain": "IE",
"variables": [
"IECAT",
"IEORRES"
],
"message": "IEORRES is not equal to 'N' when IECAT equals 'INCLUSION'.",
"errors": [
{
"value": {
"IECAT": "INCLUSION",
"IEORRES": "Y"
},
"dataset": "ie.xpt",
"row": 1,
"USUBJID": "CDISC015",
"SEQ": 1
},
{
"value": {
"IECAT": "INCLUSION",
"IEORRES": "Yes"
},
"dataset": "ie.xpt",
"row": 2,
"USUBJID": "CDISC016",
"SEQ": 1
},
{
"value": {
"IECAT": "INCLUSION",
"IEORRES": "Nope"
},
"dataset": "ie.xpt",
"row": 3,
"USUBJID": "CDISC017",
"SEQ": 1
}
]
}
]
}
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