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
Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier.
Req
IGDCMPID
Ingredient or Component Identifier
Char
Identifier
Identifier given to an ingredient, substance or component of a tobacco product represented in SPTOBID. In IQ, it must match a value of IGDCMPID in either the IT dataset (if the ingredient is a tobacco ingredient) or IN (if the ingredient is a non-tobacco ingredient).
Used to denote whether a ingredient is a single or complex ingredient (e.g., "SINGLE INGREDIENT", "COMPLEX INGREDIENT")
Exp
IQPARENT
Parent of Ingredient or Component
Char
Record Qualifier
Identifies the parent of which the ingredient or component represented in IGDCMPID is a constituent. (i.e, IGDCMPID is a child of the ingredient shown in IQPARENT). IQPARENT must equal a value of IGDCMPID from another record in the same dataset. If the ingredient is at the top level (i.e., it has no parent other than the tobacco product itself), IQPARENT will be null and IQLEVEL will be set to 1. (See IQLEVEL, below).
Perm
IQLEVEL
Ingredient Level in Hierarchy
Num
Record Qualifier
An integer that identifies the level of the ingredient or constituent within the hierarchy. The value of IQLEVEL will be n+1, where n is the IQLEVEL of the parent ingredient. IQLEVEL will be set to 1 If the ingredient is at the top level (i.e., if the ingredient has no parent ingredient/component other than the tobacco product itself). Must be populated when IQPARENT is populated.
Req
IQFUNCT
Ingredient Function
Char
Record Qualifier
The function of the ingredient in the tobacco product or the parent component. (e.g., "Adhesive", "Flavorant").
Exp
IQVALTRG
Ingredient Target Value
Num
Result Qualifier
Target value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALTRG represents the target quantity within the parent component, not the overall quantity in the tobacco product.
Req
IQVALMIN
Ingredient Minimum Value
Num
Result Qualifier
Minimum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMIN represents the minimum quantity within the parent component.
Exp
IQVALMAX
Ingredient Maximum Value
Num
Result Qualifier
Maximum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMAX represents the maximum quantity within the parent component.
Exp
IQVALU
Ingredient Value Unit
Char
(UNIT)
Result Qualifier
The single unit for the values in IQVALTRG, IQVALMIN and IQVALMAX.
Content: For variable IQIGDPLX, codelist IGDCMPLX is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
Content: For variable IQIGDPLX, CDISC Notes does not have an ending period
Content: For variable IQLEVEL, it is not a numeric variable in SDTM
Content: For variable IQVALTRG, it is not a numeric variable in SDTM
Content: For variable IQVALMIN, it is not a numeric variable in SDTM
Content: For variable IQVALMAX, it is not a numeric variable in SDTM
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.