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
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. In IT, it must be a tobacco ingredient of the product represented in SPTOBID (e.g., "Burley Tobacco", "Reconstituted Tobacco").
Req
TPMF
Tobacco Product Master File ID
Char
Identifier
The Tobacco Product Master File number, if applicable.
Perm
ITSPECIF
Specification or Variety of Tobacco Ingr
Char
Variable Qualifier
A qualifier of IGDCMPID. Used to represent the specification (variety) of tobacco ingredient (e.g., "USDA Nicotiana Collection PI 552747", "KT215LC").
Exp
ITIGDPLX
Ingredient Complexity
Char
(IGDCMPLX)
Grouping Qualifier
Used to denote whether a tobacco ingredient is a single or complex ingredient (i.e., "SINGLE INGREDIENT" or "COMPLEX INGREDIENT")
Exp
ITCIGIND
Applicant-Customized Ingredient Indic
Char
(NY)
Record Qualifier
Used to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where ITIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N".
Perm
ITCURMTH
Cure Method
Char
*
Record Qualifier
Method by which the tobacco ingredient is cured (e.g., "Air", "Sun", "Flue").
Content: For variable ITIGDPLX, codelist IGDCMPLX is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
Content: For variable ITIGDPLX, CDISC Notes does not have an ending period
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.