Sample YAML generated from spreadsheets #5
Replies: 10 comments 16 replies
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Here is the json for CG0373: {
"id": "abcffc09-b50f-46a2-bea0-0baba8d3e3c1",
"created": "2021-11-06T09:44:41Z",
"changed": "2023-03-15T16:53:41Z",
"creator": {
"id": "dd0f9aa3-68f9-4825-84a4-86c8303daaff"
},
"content": "changed: '2023-03-15T16:53:41Z'\ncontent: null\ncreated: '2021-11-06T09:44:41Z'\ncreator:\n id: dd0f9aa3-68f9-4825-84a4-86c8303daaff\nid: abcffc09-b50f-46a2-bea0-0baba8d3e3c1\njson:\n Authorities:\n - Organization: CDISC\n Standards:\n - Name: SDTMIG\n References:\n - Citations:\n - Cited_Guidance: There is a one-to-one correspondence between a domain dataset\n and it's Supplemental Qualifier dataset by creating one SUPPQUAL for each\n domain dataset. The single SUPPQUAL dataset option that was introduced\n in SDTMIG v3.1.1 is now deprecated. The set of Supplemental Qualifiers\n for each domain is included in a separate dataset with the name SUPP--\n where '--' denotes the source domain which the supplemental Qualifiers\n relate back to.\n Document: IG v3.2\n Item: ''\n Section: 8.4.2\n Origin: SDTM and SDTMIG Conformance Rules\n Rule_Identifier:\n Id: CG0373\n Version: '1'\n Version: '2.0'\n Version: '3.2'\n - Name: SDTMIG\n References:\n - Citations:\n - Cited_Guidance: There is a one-to-one correspondence between a domain dataset\n and its Supplemental Qualifier dataset. The single SUPPQUAL dataset option\n that was introduced in SDTMIG v3.1 was deprecated. The set of Supplemental\n Qualifiers for each domain is included in a separate dataset with the\n name SUPP-- where \"--\" denotes the source domain which the Supplemental\n Qualifiers relate back to.\n Document: IG v3.3\n Item: ''\n Section: 8.4.2\n Origin: SDTM and SDTMIG Conformance Rules\n Rule_Identifier:\n Id: CG0373\n Version: '1'\n Version: '2.0'\n Version: '3.3'\n - Name: SDTMIG\n References:\n - Citations:\n - Cited_Guidance: \"There is a one-to-one correspondence between a domain dataset\\\n \\ and it's Supplemental Qualifier dataset by creating one SUPPQUAL for\\\n \\ each domain dataset. The single SUPPQUAL dataset option that was introduced\\\n \\ in SDTMIG v3.1.1 is now deprecated. The set of Supplemental Qualifiers\\\n \\ for each domain is included in a separate dataset with the name SUPP--\\\n \\ where \\u201C--\\u201C denotes the source domain which the supplemental\\\n \\ Qualifiers relate back to.\"\n Document: IG v3.2\n Item: ''\n Section: 8.4.2\n Origin: SDTM and SDTMIG Conformance Rules\n Rule_Identifier:\n Id: CG0373\n Version: '1'\n Version: '2.0'\n Version: '3.4'\n Check:\n Check: null\n Core:\n Id: CDISC.SDTMIG.CG0373\n Status: Draft\n Version: '1'\n Description: Trigger error when Dataset present in study with DOMAIN not equal to\n SUPP--.RDOMAIN\n Executability: null\n Outcome:\n Message: Dataset present in study with DOMAIN not equal to SUPP--.RDOMAIN\n Rule_Type: Record Data\n Scope:\n Classes:\n Include:\n - ALL\n Domains:\n Include:\n - ALL\n Sensitivity: Record\n",
"json": {
"Check": {
"Check": null
},
"Core": {
"Id": "CDISC.SDTMIG.CG0373",
"Version": "1",
"Status": "Draft"
},
"Description": "Trigger error when Dataset present in study with DOMAIN not equal to SUPP--.RDOMAIN",
"Outcome": {
"Message": "Dataset present in study with DOMAIN not equal to SUPP--.RDOMAIN"
},
"Rule_Type": "Record Data",
"Sensitivity": "Record",
"Authorities": [
{
"Organization": "CDISC",
"Standards": [
{
"Name": "SDTMIG",
"Version": "3.2",
"References": [
{
"Origin": "SDTM and SDTMIG Conformance Rules",
"Rule_Identifier": {
"Id": "CG0373",
"Version": "1"
},
"Version": "2.0",
"Citations": [
{
"Cited_Guidance": "There is a one-to-one correspondence between a domain dataset and it's Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The set of Supplemental Qualifiers for each domain is included in a separate dataset with the name SUPP-- where '--' denotes the source domain which the supplemental Qualifiers relate back to.",
"Document": "IG v3.2",
"Item": "",
"Section": "8.4.2"
}
]
}
]
},
{
"Name": "SDTMIG",
"Version": "3.3",
"References": [
{
"Origin": "SDTM and SDTMIG Conformance Rules",
"Rule_Identifier": {
"Id": "CG0373",
"Version": "1"
},
"Version": "2.0",
"Citations": [
{
"Cited_Guidance": "There is a one-to-one correspondence between a domain dataset and its Supplemental Qualifier dataset. The single SUPPQUAL dataset option that was introduced in SDTMIG v3.1 was deprecated. The set of Supplemental Qualifiers for each domain is included in a separate dataset with the name SUPP-- where \"--\" denotes the source domain which the Supplemental Qualifiers relate back to.",
"Document": "IG v3.3",
"Item": "",
"Section": "8.4.2"
}
]
}
]
},
{
"Name": "SDTMIG",
"Version": "3.4",
"References": [
{
"Origin": "SDTM and SDTMIG Conformance Rules",
"Rule_Identifier": {
"Id": "CG0373",
"Version": "1"
},
"Version": "2.0",
"Citations": [
{
"Cited_Guidance": "There is a one-to-one correspondence between a domain dataset and it's Supplemental Qualifier dataset by creating one SUPPQUAL for each domain dataset. The single SUPPQUAL dataset option that was introduced in SDTMIG v3.1.1 is now deprecated. The set of Supplemental Qualifiers for each domain is included in a separate dataset with the name SUPP-- where \u201c--\u201c denotes the source domain which the supplemental Qualifiers relate back to.",
"Document": "IG v3.2",
"Item": "",
"Section": "8.4.2"
}
]
}
]
}
]
}
],
"Scope": {
"Classes": {
"Include": [
"ALL"
]
},
"Domains": {
"Include": [
"ALL"
]
}
},
"Executability": null
}
} |
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@htu these look great. Some comments about your samples:
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Mappings from Class to Classes: Include: Mappings from Class, Domain to Classes: Include: Mappings from Class to Domains: NOT (***) in Class or Domain should be mapped to Exclude: instead of Include: No Mapping - RELATIONSHIP |
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For reference, the CT list that has the class names: |
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I tested a few on existing rules and it merges citations correctly and passed the rule test. Here is CG0180: |
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# Variable: LBORNRLO
# Condition: LBORRES ^= continuous measurement
# Rule: LBORNRLO = null
Core:
Id: CDISC.SDTMIG.CG0180
Version: '1'
Status: Draft
Description: Raise an error when LBORRES ^= continuous measurement and LBORNRLO is
not empty.
Outcome:
Message: LBORRES is contnot inuous measurement and LBORNRLO not equal to null
Rule Type: Record Data
Sensitivity: Record
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
Version: '3.2'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0180
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: Lower end of reference range for continuous measurements
in original units. Should be populated only for continuous results.
Document: IG v3.2
Item: Specification
Section: '6.3'
- Name: SDTMIG
Version: '3.3'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0180
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: Lower end of reference range for continuous measurements
in original units. Should be populated only for continuous results.
Document: IG v3.3
Item: Specification
Section: 6.3.6
- Name: SDTMIG
Version: '3.4'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0180
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: Lower end of reference range for continuous measurements
for LBSTRESC/LBSTRESN in standardized units. Should be populated
only for continuous results.
Document: SDTMIG v3.4
Item: Specification
Section: 6.3.5.6
Scope:
Classes:
Include:
- FINDINGS
Domains:
Include:
- LB
Executability: Partially Executable
Check:
all:
- name: LBORRES
operator: non_empty
- name: LBORNRLO
operator: non_empty |
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Here is a new one: # Variable: GEN
# Condition: Variable Core Status = Required
# Rule: Variable present in dataset and ^= null
Core:
Id: CDISC.SDTMIG.CG0014
Version: '1'
Status: Draft
Description: Trigger error when Variable Core Status not equal to Required and Variable
present not in dataset and is null
Outcome:
Message: Variable Core Status not equal to Required and Variable present not in
dataset and is null
Rule Type: Record Data
Sensitivity: Variable
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
Version: '3.2'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0014
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: Required variables must always be included in the
dataset and cannot be null for any record.
Document: IG v3.2
Section: 4.1.1.5
- Name: SDTMIG
Version: '3.3'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0014
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: Required variables must always be included in the
dataset and cannot be null for any record.
Document: IG v3.3
Section: 4.1.5
- Name: SDTMIG
Version: '3.4'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0014
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: Required variables must always be included in the
dataset and cannot be null for any record.
Document: IG v3.4
Section: 4.1.5
Scope:
Classes:
Include:
- ALL
Domains:
Include:
- ALL
Executability: Partially Executable
Check:
all: []
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This is a non executable CG0196 after running through the rule builder program: # Variable: PEORRES
# Condition: PEORRES ^= null and no abnormal findings
# Rule: PEORRES = 'NORMAL'
Core:
Id: CDISC.SDTMIG.CG0196 (NOT EXECUTABLE)
Version: '1'
Status: Draft
Description: Trigger error when PEORRES is null and no abnormal fnot indnot ings and
PEORRES not equal to 'NORMAL'
Outcome:
Message: PEORRES is null and no abnormal fnot indnot ings and PEORRES not equal
to 'NORMAL'
Rule Type: Record Data
Sensitivity: Record
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
Version: '3.2'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0196
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: Text description of any abnormal findings. If the
examination was completed and there were no abnormal findings, the
value should be NORMAL.
Document: IG v3.2
Section: '6.3'
- Name: SDTMIG
Version: '3.3'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0196
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: Text description of any abnormal findings. If the
examination was completed and there were no abnormal findings, the
value should be NORMAL.
Document: IG v3.3
Section: 6.3.12
- Name: SDTMIG
Version: '3.4'
References:
- Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0196
Version: '1'
Version: '2.0'
Citations:
- Cited Guidance: If the examination was completed and there were no
abnormal findings, the value should be "NORMAL".
Document: IG v3.4
Item: Specification
Section: 6.3.8
Scope:
Classes:
Include:
- FINDINGS
Domains:
Include:
- PE
Executability: Partially Executable
Check:
all: [] |
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@htu These look really good. 2 things:
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@htu has provided the following samples for review
CG0001
CG0373
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