SDTM Non-Tobacco Ingredients (IN)

Description/Overview

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.

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.