Skip to content
Closed
Show file tree
Hide file tree
Changes from all commits
Commits
File filter

Filter by extension

Filter by extension

Conversations
Failed to load comments.
Loading
Jump to
Jump to file
Failed to load files.
Loading
Diff view
Diff view
4 changes: 4 additions & 0 deletions Unpublished/NEW-RULE/negative/01/data/.env
Original file line number Diff line number Diff line change
@@ -0,0 +1,4 @@
PRODUCT=TIG
VERSION=1-0
SUBSTANDARD=SDTM
USE_CASE=PROD
2 changes: 2 additions & 0 deletions Unpublished/NEW-RULE/negative/01/data/_datasets.csv
Original file line number Diff line number Diff line change
@@ -0,0 +1,2 @@
Filename,Label
to,Tobacco Product Identifiers and Descriptors
11 changes: 11 additions & 0 deletions Unpublished/NEW-RULE/negative/01/data/_variables.csv
Original file line number Diff line number Diff line change
@@ -0,0 +1,11 @@
dataset,variable,label,type,length
to,STUDYID,Study Identifier,Char,200
to,DOMAIN,Domain Abbreviation,Char,200
to,SPTOBID,Applicant-Defined Tobacco Product ID,Char,40
to,TOSEQ,Sequence Number,Num,10
to,TOPARMCD,Tobacco Product ID Element Short Name,Char,40
to,TOPARM,Tobacco Product ID Element Name,Char,8
to,TOCAT,Category of Tobacco Product ID Element,Char,40
to,TOSCAT,Subcategory of Tobacco Prod ID Element,Char,50
to,TOVAL,Tobacco Product ID Element Value,Char,50
to,TOVALU,Tobacco Product ID Element Value Unit,Char,50
12 changes: 12 additions & 0 deletions Unpublished/NEW-RULE/negative/01/data/to.csv
Original file line number Diff line number Diff line change
@@ -0,0 +1,12 @@
STUDYID,DOMAIN,SPTOBID,TOSEQ,TOPARMCD,TOPARM,TOCAT,TOSCAT,TOVAL,TOVALU
TOB07,TO,CIG01a,1,TBPRSCAT,Tobacco Product Category,NEW PRODUCT,PRODUCT IDENTIFIER,Cigarettes,
TOB07,TO,CIG01a,2,TBPRSCAT,Tobacco Product Subcategory,NEW PRODUCT,PRODUCT IDENTIFIER,Filtered,
TOB07,TO,CIG01a,3,MANUF,Manufacturer,NEW PRODUCT,PRODUCT IDENTIFIER,Joes Cigs USA,
TOB07,TO,CIG01a,4,MANUF,Manufacturer,NEW PRODUCT,PRODUCT IDENTIFIER,Joes Cigs USA,
TOB07,TO,CIG01a,5,TRADENAM,Trade Name,NEW PRODUCT,PRODUCT IDENTIFIER,Treetop Menthol King Size,
TOB07,TO,VAPE-Z27,1,TBPRDCATS,Tobacco Product Category,NEW PRODUCT,PRODUCT IDENTIFIER,Electronic Nicotine Delivery Systems (ENDS) (Vapes),
TOB07,TO,VAPE-Z27,2,MANUF,Tobacco Product Subcategory,NEW PRODUCT,PRODUCT IDENTIFIER,Closed E-Cigarette,
TOB07,TO,VAPE-Z27,3,MANUF,Manufacturer,NEW PRODUCT,PRODUCT IDENTIFIER,Joes Vapes USA,
TOB07,TO,VAPE-Z01,4,TRADENAM,Trade Name,NEW PRODUCT,PRODUCT IDENTIFIER,Everyday Rich Tobacco,
TOB07,TO,VAPE-Z01,5,TBPDCAT,Tobacco Product Category,NEW PRODUCT,PRODUCT IDENTIFIER,ENDS (Vapes),
TOB07,TO,VAPE-Z01,6,PRDQUAN,Product Quantity,NEW PRODUCT,PRODUCT DESCRIPTOR,E-CIGARET,
1 change: 1 addition & 0 deletions Unpublished/NEW-RULE/negative/01/results/results.csv
Original file line number Diff line number Diff line change
@@ -0,0 +1 @@
Dataset,Record,Variable,Value
4 changes: 4 additions & 0 deletions Unpublished/NEW-RULE/positive/01/data/.env
Original file line number Diff line number Diff line change
@@ -0,0 +1,4 @@
PRODUCT=TIG
VERSION=1-0
SUBSTANDARD=SDTM
USE_CASE=PROD
2 changes: 2 additions & 0 deletions Unpublished/NEW-RULE/positive/01/data/_datasets.csv
Original file line number Diff line number Diff line change
@@ -0,0 +1,2 @@
Filename,Label
to,Tobacco Product Identifiers and Descriptors
11 changes: 11 additions & 0 deletions Unpublished/NEW-RULE/positive/01/data/_variables.csv
Original file line number Diff line number Diff line change
@@ -0,0 +1,11 @@
dataset,variable,label,type,length
to,STUDYID,Study Identifier,Char,200
to,DOMAIN,Domain Abbreviation,Char,200
to,SPTOBID,Applicant-Defined Tobacco Product ID,Char,40
to,TOSEQ,Sequence Number,Num,10
to,TOPARMCD,Tobacco Product ID Element Short Name,Char,40
to,TOPARM,Tobacco Product ID Element Name,Char,8
to,TOCAT,Category of Tobacco Product ID Element,Char,40
to,TOSCAT,Subcategory of Tobacco Prod ID Element,Char,50
to,TOVAL,Tobacco Product ID Element Value,Char,50
to,TOVALU,Tobacco Product ID Element Value Unit,Char,50
12 changes: 12 additions & 0 deletions Unpublished/NEW-RULE/positive/01/data/to.csv
Original file line number Diff line number Diff line change
@@ -0,0 +1,12 @@
STUDYID,DOMAIN,SPTOBID,TOSEQ,TOPARMCD,TOPARM,TOCAT,TOSCAT,TOVAL,TOVALU
TOB07,TO,CIG01a,1,TBPRDCAT,Tobacco Product Category,NEW PRODUCT,PRODUCT IDENTIFIER,Cigarettes,
TOB07,TO,CIG01a,2,TBPRSCAT,Tobacco Product Subcategory,NEW PRODUCT,PRODUCT IDENTIFIER,Filtered,
TOB07,TO,CIG01a,3,MANUF,Manufacturer,NEW PRODUCT,PRODUCT IDENTIFIER,Joes Cigs USA,
TOB07,TO,CIG01a,4,MANUF,Manufacturer,NEW PRODUCT,PRODUCT IDENTIFIER,Joes Cigs USA,
TOB07,TO,CIG01a,5,TRADENAM,Trade Name,NEW PRODUCT,PRODUCT IDENTIFIER,Treetop Menthol King Size,
TOB07,TO,VAPE-Z27,1,TBPRDCAT,Tobacco Product Category,NEW PRODUCT,PRODUCT IDENTIFIER,Electronic Nicotine Delivery Systems (ENDS) (Vapes),
TOB07,TO,VAPE-Z27,2,TBPRDCAT,Tobacco Product Category,NEW PRODUCT,PRODUCT IDENTIFIER,Closed E-Cigarette,
TOB07,TO,VAPE-Z27,3,MANUF,Manufacturer,NEW PRODUCT,PRODUCT IDENTIFIER,Joes Vapes USA,
TOB07,TO,VAPE-Z01,4,TRADENAM,Trade Name,NEW PRODUCT,PRODUCT IDENTIFIER,Everyday Rich Tobacco,
TOB07,TO,VAPE-Z01,5,TBPRDCAT,Tobacco Product Category,NEW PRODUCT,PRODUCT IDENTIFIER,ENDS (Vapes),
TOB07,TO,VAPE-Z01,6,PRDQUAN,Product Quantity,NEW PRODUCT,PRODUCT DESCRIPTOR,E-CIGARET,
1 change: 1 addition & 0 deletions Unpublished/NEW-RULE/positive/01/results/results.csv
Original file line number Diff line number Diff line change
@@ -0,0 +1 @@
Dataset,Record,Variable,Value
57 changes: 57 additions & 0 deletions Unpublished/NEW-RULE/rule.yml
Original file line number Diff line number Diff line change
@@ -0,0 +1,57 @@
# Variable: TOPARMCD
# Rule: TOPARMCD=TBPRDCAT present in dataset
Authorities:
- Organization: 'CDISC'
Standards:
- Name: 'TIG'
References:
- Citations:
- Cited Guidance: A minimally meaningful TO dataset must include at least the
parameter for tobacco product category (TOPARMCD = TPRDCAT)
Document: 'TIG 1.0'
Item: 'assumption 2'
Section: '2.8.8.1'
Origin: TIG Conformance Rules
Rule Identifier:
Id: 'TIG0003'
Version: '1'
Version: '1.0'
Substandard: SDTM
Version: '1.0'
Check:
all:
- name: $tbprdcat_count
operator: equal_to
value: 0
Core:
Status: Draft
Version: '1'
Id: ''
Description: Raise an error when there is no record present in TO per SPTOBID
where TOPARMCD equals TBPRDCAT.
Executability: Fully Executable
Operations:
- domain: TO
filter:
TOPARMCD: TBPRDCAT
group:
- SPTOBID
id: $tbprdcat_count
name: TOPARMCD
operator: record_count
Outcome:
Message: TO dataset does not include a record for each SPTOBID where TOPARMCD =
TBPRDCAT.
Output Variables:
- SPTOBID
- $tbprdcat_count
Rule Type: Record Data
Scope:
Classes:
Include:
- STUDY REFERENCE
Domains:
Include:
- TO
Use Case: PROD
Sensitivity: Record