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Release Notes
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.
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).
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.
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%").