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12 changes: 4 additions & 8 deletions Published/CORE-000224/negative/01/results/results.csv
Original file line number Diff line number Diff line change
@@ -1,9 +1,5 @@
Dataset,Record,Variable,Value
DM,3,ACTARM,
DM,3,ARMNRS,
DM,4,ACTARM,
DM,4,ARMNRS,
DM,5,ACTARM,
DM,5,ARMNRS,
DM,6,ACTARM,
DM,6,ARMNRS,
DM,4,USUBJID,CDISC004
DM,5,USUBJID,CDISC005
DM,6,USUBJID,CDISC006
DM,7,USUBJID,CDISC007
2 changes: 0 additions & 2 deletions Published/CORE-000224/negative/02/data/.env

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3 changes: 0 additions & 3 deletions Published/CORE-000224/negative/02/data/_datasets.csv

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36 changes: 0 additions & 36 deletions Published/CORE-000224/negative/02/data/_variables.csv

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10 changes: 0 additions & 10 deletions Published/CORE-000224/negative/02/data/ae.csv

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5 changes: 0 additions & 5 deletions Published/CORE-000224/negative/02/data/dm.csv

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2 changes: 0 additions & 2 deletions Published/CORE-000224/negative/02/results/results.csv

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122 changes: 59 additions & 63 deletions Published/CORE-000224/rule.yml
Original file line number Diff line number Diff line change
Expand Up @@ -2,84 +2,80 @@
# Condition: ACTARM = null
# Rule: ARMNRS^=null
Authorities:
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: With the exception of studies which use multi-stage Arm
assignments, must be a value of ARM in the Trial Arms Dataset.
If the subject was not assigned to an Arm or followed a course
not described by any planned Arm, ACTARM is null and ARMNRS is
populated.
Document: IG v3.4
Item: Specification
Section: '5.2'
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0515
Version: '1'
Version: '2.0'
Version: '3.4'
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: With the exception of studies which use multi-stage arm
assignments, must be a value of ARMCD in the Trial Arms
Dataset. If the subject was not assigned to an arm or followed
a course not described by any planned arm, ACTARMCD is null
and ARMNRS is populated.
Document: IG v3.3
Item: Specification
Section: '5.2'
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0515
Version: '1'
Version: '2.0'
Version: '3.3'
- Name: TIG
References:
- Citations:
- Cited Guidance: With the exception of studies which use multi-stage Arm
assignments, must be a value of ARMCD in the Trial Arms
Dataset. If the subject was not assigned to an Arm or followed
a course not described by any planned Arm, ACTARMCD is null
and ARMNRS is populated.
Document: TIG 1.0
Item: Specification:ARMNRS
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0610
Version: '1'
Version: '1.0'
Substandard: SDTM
Version: '1.0'
- Organization: CDISC
Standards:
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be
a value of ARM in the Trial Arms Dataset. If the subject was not assigned to an Arm or
followed a course not described by any planned Arm, ACTARM is null and ARMNRS is
populated.
Document: IG v3.4
Item: Specification
Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0515
Version: "1"
Version: "2.0"
Version: "3.4"
- Name: SDTMIG
References:
- Citations:
- Cited Guidance: With the exception of studies which use multi-stage arm assignments, must be
a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an arm or
followed a course not described by any planned arm, ACTARMCD is null and ARMNRS is
populated.
Document: IG v3.3
Item: Specification
Section: "5.2"
Origin: SDTM and SDTMIG Conformance Rules
Rule Identifier:
Id: CG0515
Version: "1"
Version: "2.0"
Version: "3.3"
- Name: TIG
References:
- Citations:
- Cited Guidance: With the exception of studies which use multi-stage Arm assignments, must be
a value of ARMCD in the Trial Arms Dataset. If the subject was not assigned to an Arm or
followed a course not described by any planned Arm, ACTARMCD is null and ARMNRS is
populated.
Document: TIG 1.0
Item: Specification:ARMNRS
Section: 2.8.10.4
Origin: TIG Conformance Rules
Rule Identifier:
Id: TIG0610
Version: "1"
Version: "1.0"
Substandard: SDTM
Version: "1.0"
Check:
all:
- name: ACTARM
operator: empty
- name: ARMNRS
operator: empty
- name: ACTARM
operator: empty
- name: ARMNRS
operator: empty
Core:
Id: CORE-000224
Status: Published
Version: '1'
Version: "1"
Description: Raise an error when ACTARM is empty and ARMNRS is not completed.
Executability: Fully Executable
Outcome:
Message: ACTARM is empty, but ARMNRS is not completed.
Output Variables:
- ACTARM
- ARMNRS
- USUBJID
Rule Type: Record Data
Scope:
Classes:
Include:
- SPECIAL PURPOSE
- SPECIAL PURPOSE
Domains:
Include:
- DM
- DM
Use Case: INDH
Sensitivity: Record
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