SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1
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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist or Format1
Role
CDISC Notes
Core
STUDYID
Study Identifier
Char
Identifier
Unique identifier for a study.
Req
DOMAIN
Domain Abbreviation
Char
IQ
Identifier
Two-character abbreviation for the domain.
Req
SPTOBID
Sponsor-Defined Tobacco Product ID
Char
Identifier
Sponsor-defined identifier for a Tobacco Product. SPTOBID should be populated with an intuitive name based on a description of the tobacco product (e.g., "CIG104"; "ENDS01A", etc). It must be unique for each unique tobacco product as defined by the specific values of the product's IQPARMCD-IQVAL pairs.
Req
INGCMPID
Ingredient or Component Identifier
Char
Identifier
Identifier given to an ingredient, substance or component of a tobacco product. In IN, it must be a non-tobacco ingredient of the product represented in SPTOBID (e.g., "Cocoa Extract", "Cellulose Pulp").
Req
INCAT
Category of Tobacco Ingredient
Char
SINGLE INGREDIENT, COMPLEX INGREDIENT
Grouping Qualifier
Used to denote whether a tobacco ingredient is a single or complex ingredient.
Exp
IQPARENT
Complex Ingredient Customized Indicator
Char
(NY)
Record Qualifier
Used to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where INCAT = COMPLEX INGREDIENT.
Perm
IQLEVEL
Grade
Char
Record Qualifier
The grade of the ingredient represented in INGCMPID (e.g., "FOOD")
IQFUNCT
Purity
Char
Record Qualifier
The purity of the ingredient represented in INGCMPID (e.g., "99%", ">99%").
IQVALTRG
Design Parameter Element Target Value
Char
*
Result Qualifier
Target value, according to the manufacturer's design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID.
Req
IQVALMIN
Design Parameter Element Minimum Value
Char
Result Qualifier
Minimum allowable value, according to the manufacturer's design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID.
Exp
IQVALMAX
Design Parameter Element Maximum Value
Char
Result Qualifier
Maximum allowable value, according to the manufacturer's design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID.
Exp
IQVALU
Design Parameter Element Value Unit
Char
(UNIT)
Result Qualifier
The single unit for the values in IQVALTRG, IQVALMIN and IQVALMAX. Will be blank for unitless parameters (e.g., "Number of Heating Elements"). Must be used where applicable (e.g., "Circumference").
Content: For variable INCAT, SINGLE INGREDIENT, COMPLEX INGREDIENT is a not a recognized content for Controlled Terms, Codelist or Format1
Content: For variable IQLEVEL, CDISC Notes does not have an ending period
Content: For variable IQLEVEL, a value is missing in Core
Content: For variable IQFUNCT, a value is missing in Core
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.