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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied. Make sure all Confluence WIKI macros e.g., JIRA, Status, are removed prior to publication. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharITIdentifierTwo-character abbreviation for the domain.Req
SPTOBIDApplicant-Defined Tobacco Product IDChar
IdentifierIdentifier 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
IGDCMPIDIngredient or Component IdentifierChar
IdentifierIdentifier 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
IdentifierThe Tobacco Product Master File number, if applicable.Perm
ITSPECIF

Specification or Variety of Tobacco Ingr TOBA-308 - Getting issue details... STATUS TOBA-201 - Getting issue details... STATUS

Char
Variable QualifierA qualifier of IGDCMPID. Used to represent the specification (variety) of tobacco ingredient (e.g., "USDA Nicotiana Collection PI 552747", "KT215LC").Exp
ITIGDPLXIngredient ComplexityChar(IGDCMPLX)Grouping QualifierUsed 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 QualifierUsed 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
ITCURMTHCure MethodChar*Record QualifierMethod by which the tobacco ingredient is cured (e.g., "Air", "Sun", "Flue").Exp
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