Description

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

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


Specification

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

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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 AbbreviationCharINIdentifierTwo-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

IGDCMPID

Ingredient or Component IdentifierChar
IdentifierIdentifier given to an ingredient, substance or component of a product. In IN, it must be a non-tobacco ingredient of the product represented in SPTOBID (e.g., "Cocoa Extract", "Cellulose Pulp").Req
INMANUFManufacturer NameChar
IdentifierThe name of the manufacturer of a complex ingredient/component represented in IGDCMPID. Does not need to be populated for single ingredients.Perm
INMANUIN

Manufacturer Unique Identifying Item Num

Char
Identifier

The unique identifying item number assigned by the manufacturer to the ingredient or component shown in IGDCMPID (e.g, catalog number).

Perm

TPMF

Tobacco Product Master File Number

Char
Identifier

The Tobacco Product Master File number for the ingredient/component represented in IGDCMPID, if applicable. Used for proprietary purchased ingredients when the manufacturer does not want to disclose the formula to the public and has instead provided these details in a file directly to regulators.

Perm
IUPACNAMPreferred IUPAC NameChar

IUPAC Nomenclature

IdentifierThe preferred International Union of Pure and Applied Chemistry (IUPAC) name of the ingredient represented in IGDCMPID, if applicable.Exp
CASNO

CAS Registry Number

Char

CAS

IdentifierThe Chemical Abstract Service (CAS) registry number for the ingredient represented in IGDCMPID.Perm

UNII

Unique Ingredient Identifier

CharUNIIIdentifierThe FDA Unique Ingredient Identifier (UNII) number for the ingredient represented in IGDCMPID.Perm
INIGDPLXIngredient ComplexityChar(IGDCMPLX)Grouping QualifierUsed to denote whether an ingredient is a single or complex ingredient (i.e.,., "SINGLE INGREDIENT", "COMPLEX INGREDIENT").Exp
INCIGIND

Applicant-Customized Ingredient Indic

Char(NY)Record QualifierUsed to indicate whether a complex ingredient was made to the applicant's specification. Expected to be populated where INIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N".Perm
INGRADE

Ingredient Grade

Char


Record QualifierThe grade of the ingredient represented in IGDCMPID (e.g., "USP", "FOOD").Exp
INPURITY

Ingredient Purity

Char
Record QualifierThe purity of the ingredient represented in IGDCMPID, provided for any ingredient for which this information is available (e.g., "99%", ">99%").Exp


Assumptions

  1.  IN is a special-purpose domain for listing the non-tobacco ingredients (only) for a tobacco product. Tobacco ingredients (e.g., individual tobacco varieties) would not be represented in this domain (see Section 2.8.8.4, SDTM Tobacco Ingredients, for IT domain specification and assumptions).
  2. IN is 1 of 2 domains (along with IT) that serve as the origin of the consistent identifier variable IGDCMPID (Ingredient or Component Identifier).
    1. IGDCMPID must represent a non-tobacco ingredient that is unique with regard to the attributes listed in assumption 3 below. If 2 or more sources of the same non-tobacco ingredient differ on any of these attributes, they must each be assigned a different value for IGDCMPID (e.g., 1,3-Butanediol A, 1,3-Butanediol B).
    2. IGDCMPID is also used in the Ingredient Quantities by Component (IQ) domain, where the ingredients identified by those values are quantified by component. When quantifying ingredients in IQ, every ingredient (every value of IGDCMPID in IN) must be accounted for in IQ (see Section 2.8.8.6 for IQ domain specification and assumptions).
  3. Additionally, IN contains variables for representing the following attributes:
    1. Manufacturer's name and registration number (INMANUF)
    2. Manufacturer's unique identifying item number for the ingredient or component (INMANUIN)
    3. Tobacco product master file number (TPMF)
    4. IUPAC name (IUPACNAM), CAS registry number (CASNO), and FDA Unique Ingredient Identifier (UNII), with the following requirements for inclusion in the IN dataset:
      1. IUPACNAM is an expected variable, and should be populated with the preferred IUPAC name for all ingredients for which an IUPAC name is available. IUPAC nomenclature is available at https://iupac.org/.
      2. At least 1 of the 2 permissible variables CASNO or UNII should also be provided if available. CAS numbers are available at https://www.cas.org/. UNII identifiers are available https://precision.fda.gov/uniisearch. 
    5. The complexity of the ingredient (INIGDPLX), to differentiate between single ingredients and complex ingredients, and a separate indicator (INCIGIND) as to whether a complex ingredient was made to the applicant's specifications
    6. Ingredient grade (INGRADE) and purity (INPURITY). According to the PMTA rule, at least 1 of these 2 attributes must be included. If the data are proprietary and only available via the TPMF, then TPMF should be populated. 

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