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Description TOBA-234 - Getting issue details... STATUS

A special purpose domain for representing the quantity of an ingredient/component of a product by the parent ingredient/component in which it occurs.

iq.xpt, Ingredient Quantities by Component — Special-Purpose. One record per ingredient/component (IGDCMPID) per parent ingredient/component, Tabulation.


Specification

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

Metadata check macro is applied and detected no issues. 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. 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 AbbreviationCharIQIdentifierTwo-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
Identifier

Identifier given to an ingredient, substance or component of a tobacco product represented in SPTOBID. In IQ, it must match a value of IGDCMPID in either the IT dataset (if the ingredient is a tobacco ingredient) or IN (if the ingredient is a non-tobacco ingredient).

(e.g., "Burley Tobacco", "Propylene Glycol", "Cocoa Extract", "Cellulose Pulp").

Req
IQCATCategory of Ingredient or ComponentChar

(IQCAT)

Grouping Qualifier

Used to group ingredients/components by tobacco and non-tobacco ingredients. Required to enable conformance checks to ensure IGDCMPID is present in either the IT or IN domain.

Req
IQIGDPLXIngredient ComplexityChar(IGDCMPLX)Grouping QualifierUsed to denote whether a ingredient is a single or complex ingredient (e.g., "SINGLE INGREDIENT", "COMPLEX INGREDIENT").Exp

IQPARENT

Parent of Ingredient or Component

Char
Record Qualifier

Identifies the parent of which the ingredient or component represented in IGDCMPID is a part. (i.e, IGDCMPID is a child of the ingredient shown in IQPARENT). IQPARENT must equal a value of IGDCMPID from another record in the same dataset. IQPARENT will therefore always be a complex ingredient. If the ingredient is at the top level (i.e., it has no parent other than the tobacco product itself), IQPARENT will be null and IQLEVEL will be set to 1. (See IQLEVEL, below).

Perm
IQLEVEL

Ingredient Level in Hierarchy

Num
Record QualifierAn integer that identifies the level of the ingredient or component within the hierarchy. The value of IQLEVEL will be n+1, where n is the IQLEVEL of the parent ingredient. IQLEVEL will be set to 1 If the ingredient is at the top level (i.e., if the ingredient has no parent ingredient/component other than the tobacco product itself). Must be populated when IQPARENT is populated.Req
IQFUNCT

Ingredient Function

Char
Record QualifierThe function of the ingredient in the tobacco product or the parent component. (e.g., "Adhesive", "Flavorant").Exp
IQVALTRGIngredient Target ValueNum
Result QualifierTarget value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALTRG represents the target quantity within the parent component, not the overall quantity in the tobacco product.Req
IQVALMIN

Ingredient Minimum Value

Num
Result QualifierMinimum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMIN represents the minimum quantity within the parent component.Exp
IQVALMAX

Ingredient Maximum Value

Num
Result QualifierMaximum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMAX represents the maximum quantity within the parent component.Exp
IQVALUIngredient Value UnitChar(UNIT)Result QualifierThe single unit for the values in IQVALTRG, IQVALMIN and IQVALMAX.Exp


Assumptions

  1.  IQ is a special-purpose domain for listing the target, minimum, and maximum quantities of both tobacco ingredients and non-tobacco ingredients of a tobacco product. These values represent design specifications, not test data. IQ additionally shows the function of each ingredient by component in which the ingredient appears.
  2. IGDCMPID represents the unique ingredient name established in either the Tobacco Ingredients (IT) domain or the Non-Tobacco Ingredients (IN) domain. Therefore, every value of IDGCMPID in the IQ domain must have an exact match in either IT or IN (See Sections 2.8.8.4 and 2.8.8.5 for IT and IN domain specifications and assumptions). 
  3. IQCAT represents whether the ingredient is a tobacco ingredient or a non-tobacco ingredient. Populating this variable facilitates checks for conformance to assumption 2. 
  4. Ingredients that appear in more than 1 component of the tobacco product (or which are part of a complex ingredient) are quantified separately for each component/complex ingredient in which they appear. The hierarchical relationship of these ingredients is made explicit by the use of the IQPARENT and IQLEVEL variables as follows:
    1. IQPARENT represents the complex ingredient or component of the tobacco product in which ingredient or subcomponent (IDGCMPID for the record) appears. 
      1. IQPARENT must equal the IDGCMPID of another record in IQ (i.e., the parent ingredient/component must be listed in IQ).
      2. If the ingredient is not a part of another ingredient or component (i.e., it is a top-level component with no parent other than the tobacco product itself) IQPARENT is null.
    2. IQLEVEL is an integer that represents the level in the hierarchy of an ingredient's relationship to other ingredients.
      1. IQLEVEL cannot be null. Every ingredient, including top-level ingredients as defined in assumption 4.a.ii, must have a value for IQLEVEL.
      2. Top-level ingredients have IQLEVEL = 1
      3. Subcomponents of complex ingredients have IQLEVEL = n+1, where n equals the IQLEVEL of the parent ingredient or component.
  5. IQFUNCT is used to represent the function of the ingredient in the component in which it appears (e.g., FLAVORANT, ADHESIVE).

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