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 IDGCMPID 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 tobacco 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 ofIGDCMPID 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).
IQFUNCT
Purity
Char
Record Qualifier
The purity of the ingredient represented in IGDCMPID (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 IGDCMPID, non-ASCII characters (highlighted text in table), found in CDISC Notes; offending characters list: [ ]
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 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.