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DOMAINSTUDYIDSPTOBIDINGCMPIDINMANUFINMANUFNTPMFIUPACNAMCASNOINCATINSPFLINGRADEINPURTY

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
IdentifierSponsor-defined identifier for a Tobacco Product. SPTOBID should be populated with an intuitive name based on a description of the tobacco product (e.g., "CIG104"; "ENDS01A", etc). It must be unique for each unique tobacco product as defined by the specific values of the product's PDPARMCD-PDVAL pairs.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. Does not need to be populated for single ingredients.Perm
INMANUFNManufacturer Registration NumberChar
IdentifierThe registration number of the manufacturer of a complex ingredient/component. 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, 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 NumberCharCAS IdentifierThe Chemical Abstract Service (CAS) registry number for the ingredient represented in INGCMPID, if applicable.  Exp
INCATCategory of Tobacco IngredientCharSINGLE INGREDIENT, COMPLEX INGREDIENTGrouping QualifierUsed to denote whether a tobacco ingredient is a single or complex ingredient.Exp
INSPFL

Complex Ingredient Customized Indicator

Char(NY)Record QualifierUsed to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where INCAT = COMPLEX INGREDIENT.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, non-ASCII characters (highlighted text in table), found in Controlled Terms, Codelist or Format1; offending characters list: [ ]
  • Content: For variable CASNO, CAS is a not a recognized content for Controlled Terms, Codelist or Format1
  • Content: For variable CASNO, non-ASCII characters (highlighted text in table), found in CDISC Notes; offending characters list: [ ,  ]
  • Content: For variable INCAT, SINGLE INGREDIENT, COMPLEX INGREDIENT is a not a recognized content for Controlled Terms, Codelist or Format1
  • 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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