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Description
Standard
FDA BR SDTMIG
Reference Rule ID(s)
FB3001
Conformance Rule ID(s) (if published in CORE)
CORE-000699
JIRA Ticket
https://jira.cdisc.org/projects/CORERULES/issues/CORERULES-9309
CLI Command Used (if applicable)
NAP
Rule YAML
Authorities:
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: '3.2'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: '3.3'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: '3.4'
- Name: SENDIG
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: '3.0'
- Name: SENDIG
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: '3.1'
- Name: SENDIG
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: 3.1.1
- Name: SENDIG-GENETOX
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: '1.0'
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: '1.1'
- Name: SENDIG-DART
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: '1.2'
- Name: SENDIG-AR
References:
- Citations:
- Cited Guidance: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD
values).
Document: FDA
Section: FDAB030
Origin: FDA Business Rules
Rule Identifier:
Id: FB3001
Version: '1'
Version: '1.5'
Version: '1.0'
Check:
all:
- name: --STRESU
operator: is_inconsistent_across_dataset
value:
- --TESTCD
- --CAT
- --SCAT
- --SPEC
- --METHOD
- --STAT
Core:
Id: CORE-000699
Status: Published
Version: '1'
Description: Standard units should be consistent within the same assessment
(having the same --TESTCD, --CAT, --SCAT, --SPEC, --METHOD values)
Executability: Fully Executable
Grouping_Variables:
- --TESTCD
- --CAT
- --SCAT
- --SPEC
- --METHOD
Outcome:
Message: Standards units are inconsistent within the same test (category,
sub-category, specimen and method)
Output Variables:
- --STRESU
- --TESTCD
- --CAT
- --SCAT
- --SPEC
- --METHOD
- --STAT
Rule Type: Record Data
Scope:
Classes:
Include:
- FINDINGS
- FINDINGS ABOUT
Domains:
Include:
- ALL
Sensitivity: GroupAttach any sample test data file(s)
test data available on sharepoint
Attach any output report and/or log file(s)
Expected output
wildcard should be accepted so variables are recognized and rule can work across all Findings domains
Any Additional Information
It seems the wildcard is not working for the grouping_variables property, as rule does not recognize the grouping_variables. FB3001 could benefit from grouping_variables to meaningfully reduce the number of output records, but it would need the wildcard since rule is applicable for all Findings domains. Thanks for looking into this!
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Labels
SDTMCDISC SDTM/SDTMIGCDISC SDTM/SDTMIG