SDTM Non-Tobacco Ingredients (IN)

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

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Variable Name	Variable Label	Type	Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char		Identifier	Unique 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
DOMAIN	Domain Abbreviation	Char	IN	Identifier	Two-character abbreviation for the domain.	Req
SPTOBID	Applicant-Defined Tobacco Product ID	Char		Identifier	Identifier 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 Identifier	Char		Identifier	Identifier 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
INMANUF	Manufacturer Name	Char		Identifier	The 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
IUPACNAM	Preferred IUPAC Name	Char	IUPAC Nomenclature	Identifier	The 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	Identifier	The Chemical Abstract Service (CAS) registry number for the ingredient represented in IGDCMPID.	Perm
UNII	Unique Ingredient Identifier	Char	UNII	Identifier	The FDA Unique Ingredient Identifier (UNII) number for the ingredient represented in IGDCMPID.	Perm
INIGDPLX	Ingredient Complexity	Char	(IGDCMPLX)	Grouping Qualifier	Used 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 Qualifier	Used 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 Qualifier	The grade of the ingredient represented in IGDCMPID (e.g., "USP", "FOOD").	Exp
INPURITY	Ingredient Purity	Char		Record Qualifier	The purity of the ingredient represented in IGDCMPID, provided for any ingredient for which this information is available (e.g., "99%", ">99%").	Exp

Assumptions

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).
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).
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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SDTM Non-Tobacco Ingredients (IN)