SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1
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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist or Format1
Role
CDISC Notes
Core
STUDYID
Study Identifier
Char
Identifier
Unique identifier for a study.
Req
DOMAIN
Domain Abbreviation
Char
IN
Identifier
Two-character abbreviation for the domain.
Req
SPTOBID
Sponsor-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 tobacco 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
INMANUFN
Manufacturer Registration Number
Char
Identifier
The registration number of the manufacturer of a complex ingredient/component represented in IGDCMPID. Does not need to be populated for single ingredients.
Perm
TPMF
Tobacco Product Master File Number
Char
Identifier
The Tobacco Product Master File number for the ingredient/component represented in IGDCMPID, if applicable.
Perm
IUPACNAM
IUPAC Name
Char
IUPAC
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, if applicable.
Exp
INIGDPLX
Ingredient Complexity
Char
(IGDCMPLX)
Grouping Qualifier
Used to denote whether a tobacco ingredient is a single or complex ingredient (e.g., "SINGLE INGREDIENT", "COMPLEX INGREDIENT")
Exp
INCIGIND
Applicant-Customized Ingredient Indic
Char
(NY)
Record Qualifier
Used to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where INIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N".
Perm
INGRADE
Grade
Char
Record Qualifier
The grade of the ingredient represented in IGDCMPID (e.g., "FOOD")
INPURITY
Purity
Char
Record Qualifier
The purity of the ingredient represented in IGDCMPID (e.g., "99%", ">99%").
Content: For variable IUPACNAM, IUPAC is a not a recognized content for Controlled Terms, Codelist or Format1
Content: For variable CASNO, CAS is a not a recognized content for Controlled Terms, Codelist or Format1
Content: For variable INIGDPLX, codelist IGDCMPLX is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
Content: For variable INIGDPLX, CDISC Notes does not have an ending period
Content: For variable INGRADE, CDISC Notes does not have an ending period
Content: For variable INGRADE, a value is missing in Core
Content: For variable INPURITY, a value is missing in Core
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.