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
IT
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).
Req
INGCMPID
Ingredient or Component Identifier
Char
Identifier
Identifier given to an ingredient, substance or component of a tobacco product. In IT, it must be a tobacco ingredient of the product represented in SPTOBID (e.g., "Burley Tobacco", "Reconstituted Tobacco").
Req
ITSPECIF
Specification or Variety of Tobacco Ingr
Char
Variable Qualifier
A qualifier of INGCMPID. Used to represent the specification (variety) of tobacco ingredient (e.g., "USDA Nicotiana Collection PI 552747", "KT215LC").
Exp
ITCAT
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
ITCURMTH
Cure Method
Char
*
Record Qualifier
Method by which the tobacco ingredient is cured (e.g., "Air", "Sun", "Flue").
Exp
ITSPFL
Complex Ingredient Specification Flag
Char
(NY)
Record Qualifier
Used to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where ITCAT = COMPLEX INGREDIENT. Values restricted to "Y" or "N".
Perm
TPMF
Tobacco Product Master File ID
Char
Identifier
The Tobacco Product Master File number, if applicable.
Content: For variable ITCAT, SINGLE INGREDIENT, COMPLEX INGREDIENT is a not a recognized content for Controlled Terms, Codelist or Format1
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.