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Metadataspec
highlighttrue
keysCDISC Notes;Core
shareqc_sdtmig34sdtm4tig10_ds
ClassSpecial Purpose
DomainIT
Variable NameVariable LabelTypeControlled Terms, Codelist, or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected.Req
DOMAINDomain AbbreviationCharITIdentifierTwo-character abbreviation for the domain.Req
SPTOBIDSponsorApplicant-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

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-308
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-201

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.g., "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").ExpTPMF

Tobacco Product Master File ID

CharIdentifierThe Tobacco Product Master File number, if applicable.Perm
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.