Standard
FDA BR SDTM, CDISC SDTM/SDTMIG
Reference Rule ID(s)
CG0067/FB0614
Conformance Rule ID(s) (if published in CORE)
CORE-000251
JIRA Ticket
https://jira.cdisc.org/projects/CORERULES/issues/CORERULES-
CLI Command Used (if applicable)
python core.py -s SDTM -v 3.4 -d /path/to/datasets
Rule YAML
# Variable: DSDECOD
# Condition: SS.SSSTRESC = 'DEAD'
# Rule: DSDECOD = 'DEATH'
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: For example, if a subject's survival status is "DEAD", the date
of death must be stored in DM and within a final disposition
record in DS.
Document: SDTMIG v3.4
Item: Assumption 1
Section: 6.3.11
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0067
Version: '1'
Version: '2.0'
Version: '3.4'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date
of death must be stored in DM and within a final disposition
record in DS.
Document: SDTMIG v3.3
Item: Assumption 1
Section: 6.3.15
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0067
Version: '1'
Version: '2.0'
Version: '3.3'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: For example, if a subject's Survival Status is "DEAD", the date
of death must be stored in DM and within a final disposition
record in DS.
Document: SDTMIG v3.2
Item: Assumption 2
Section: '6.3'
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0067
Version: '1'
Version: '2.0'
Version: '3.2'
#CG0067 is identical to rule FB0614. Added metadata for FB0614 by Malini Narreddy on 2025-03-07
- Organization: FDA
Standards:
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0614
Version: '1'
Version: '1.5'
Version: '3.2'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0614
Version: '1'
Version: '1.5'
Version: '3.3'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: All death information should be populated for subjects that died
during the study including any post treatment follow-up.
Document: FDA
Section: FDAB006
Origin: FDA Business Rules
Rule Identifier:
Id: FB0614
Version: '1'
Version: '1.5'
Version: '3.4'
Check:
all:
- name: SSSTRESC
operator: equal_to
value: DEAD
value_is_literal: true
- name: $ds_dsdecod
operator: does_not_contain
value: DEATH
value_is_literal: true
Core:
Id: CORE-000251
Status: Published
Version: '1'
Description: When SS.SSSTRESC = "DEAD", the final disposition record must have
DSDECOD ^= "DEATH".
Executability: Fully Executable
Operations:
- domain: DS
group:
- USUBJID
id: $ds_dsdecod
name: DSDECOD
operator: distinct
Outcome:
Message: DSDECOD is not "DEATH", When SS.SSSTRESC = "DEAD".
Output Variables:
- SSSTRESC
- $ds_dsdecod
Rule Type: Record Data
Scope:
Classes:
Include:
- FINDINGS
Domains:
Include:
- SS
Sensitivity: Record
Attach any sample test data file(s)
unit-test-coreid-CG0067-negative.xlsx
Attach any output report and/or log file(s)
results.txt
Expected output
results.txt
Any Additional Information
To get the provided expected output
Changed from:
return self._handle_target_is_collection(target, comparator)
To:
return self._handle_target_is_collection(target, comparator,
value_is_literal)
in
engine/cdisc_rules_engine/check_operators/sql/contains_operator.py
Standard
FDA BR SDTM, CDISC SDTM/SDTMIG
Reference Rule ID(s)
CG0067/FB0614
Conformance Rule ID(s) (if published in CORE)
CORE-000251
JIRA Ticket
https://jira.cdisc.org/projects/CORERULES/issues/CORERULES-
CLI Command Used (if applicable)
python core.py -s SDTM -v 3.4 -d /path/to/datasets
Rule YAML
Attach any sample test data file(s)
unit-test-coreid-CG0067-negative.xlsx
Attach any output report and/or log file(s)
results.txt
Expected output
results.txt
Any Additional Information
To get the provided expected output
Changed from:
return self._handle_target_is_collection(target, comparator)
To:
return self._handle_target_is_collection(target, comparator,
value_is_literal)
in
engine/cdisc_rules_engine/check_operators/sql/contains_operator.py