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SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharINIdentifierTwo-character abbreviation for the domain.Req
SPTOBIDSponsor-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
INGCMPIDIngredient or Component IdentifierChar
IdentifierIdentifier 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
INMANUFManufacturer NameChar
IdentifierThe name of the manufacturer of a complex ingredient/component represented in INGCMPID. Does not need to be populated for single ingredients.Perm
INMANUFNManufacturer Registration NumberChar
IdentifierThe registration number of the manufacturer of a complex ingredient/component represented in INGCMPID. Does not need to be populated for single ingredients.Perm
TPMF

Tobacco Product Master File Number

Char
IdentifierThe Tobacco Product Master File number for the ingredient/component represented in INGCMPID, if applicable.Perm
IUPACNAMIUPAC NameCharIUPACIdentifierThe preferred International Union of Pure and Applied Chemistry (IUPAC) name of the ingredient represented in INGCMPID, if applicable.Exp
CASNOCAS Registry NumberCharCASIdentifierThe Chemical Abstract Service (CAS) registry number for the ingredient represented in INGCMPID, if applicable.Exp
INIGDPLXIngredient ComplexityChar(IGDCMPLX)Grouping QualifierUsed 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 QualifierUsed 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 QualifierThe grade of the ingredient represented in INGCMPID (e.g., "FOOD")
INPURITY

Purity

Char
Record QualifierThe purity of the ingredient represented in INGCMPID (e.g., "99%", ">99%").

Metadata Checks Findings

SDTMIG v3.3 Metadata Check User Macros FAQ
  • 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.

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