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Description  TOBA-199 - Getting issue details... STATUS

A special-purpose domain that provides an identifier for each unique tobacco ingredient (IGDCMPID) in a tobacco product, and lists those tobacco ingredients and their attributes that contribute to their uniqueness.

it.xpt, Tobacco Ingredients — Special-Purpose. One record per unique tobacco ingredient per applicant-defined tobacco product, Tabulation.


Specification

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Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC 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
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


Assumptions

  1.  IT is a special-purpose domain for listing the tobacco ingredients (only) for a tobacco product. Non-tobacco ingredients (e.g., wrapping paper, filter) would not be represented in this domain (see Section 2.8.8.5, Non-Tobacco Ingredients, for specification, assumptions, and other information on non-tobacco ingredients).
  2. IT is 1 of 2 domains (along with IN) that serve as the origin of the consistent identifier variable IGDCMPID (Ingredient or Component Identifier).
    1. IGDCMPID must represent a unique tobacco ingredient with regard to the attributes listed in assumptions 3a-3c. If 2 or more sources of the same variety of tobacco ingredient differ on any of these attributes, they must each be assigned a different value for IDGCMPID (e.g., Burley Tobacco 1, Burley Tobacco 2)
    2. IGDCMPID is also used in the Ingredient Quantities by Component (IQ) domain (see Section 2.8.8.6), where the ingredients identified by those values are quantified by component. When quantifying ingredients in IQ, every ingredient (every value of IGDCMPID in IT) must be accounted for in IQ.
  3. IT additionally contains variables for representing the following attributes of each tobacco ingredient:
    1. Tobacco product master file, if applicable
    2. Specification or variety of the tobacco
    3. Complexity of the ingredient, to differentiate between single tobacco ingredients and complex ingredients (tobacco blends), and a separate indicator as to whether a complex tobacco ingredient was made to specifications
    4. Tobacco cure method
  4. At least 1 record representing the overall tobacco component/tobacco filler for the product must be included in the dataset. The individual tobacco ingredients of which the overall tobacco filler/component of the tobacco product is comprised must also be represented, if available. This will be necessary when quantifying the ingredients in the IQ domain.

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