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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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 FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharINIdentifierTwo-character abbreviation for the domain.Req
SPTOBIDApplicant-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
IGDCMPIDIngredient or Component IdentifierChar
IdentifierIdentifier 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
INMANUFManufacturer NameChar
IdentifierThe 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 TOBA-181 - Getting issue details... STATUS

Char
Identifier

The unique identifying item number assigned by the manufacturer to the ingredient or component shown in IGDCMPID (e.g, catalog number). TOBA-182 - Getting issue details... STATUS

Perm
TPMF

Tobacco Product Master File Number

Char
Identifier

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. TOBA-318 - Getting issue details... STATUS

Perm
IUPACNAMPreferred IUPAC NameCharIUPACIdentifierThe preferred International Union of Pure and Applied Chemistry (IUPAC) name of the ingredient represented in IGDCMPID, if applicable.Exp
CASNO

CAS Registry Number TOBA-183 - Getting issue details... STATUS

CharCASIdentifierThe Chemical Abstract Service (CAS) registry number for the ingredient represented in IGDCMPID.Perm
UNII

Unique Ingredient Identifier

CharUNIIIdentifierThe FDA Unique Ingredient Identifier (UNII) number for the ingredient represented in IGDCMPID.Perm
INIGDPLXIngredient ComplexityChar(IGDCMPLX)Grouping QualifierUsed 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 QualifierUsed to indicate whether a complex ingredient was made to the applicant's specification. TOBA-312 - Getting issue details... STATUS Expected to be populated where INIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N".Perm
INGRADE

Ingredient Grade TOBA-316 - Getting issue details... STATUS

Char

TOBA-96 - Getting issue details... STATUS

Record QualifierThe grade of the ingredient represented in IGDCMPID (e.g., "USP", "FOOD").Exp
INPURITY

Ingredient Purity TOBA-317 - Getting issue details... STATUS

Char
Record QualifierThe purity of the ingredient represented in IGDCMPID, provided for any ingredient for which this information is available (e.g., "99%", ">99%").Exp

Metadata Checks Findings

Metadata Check User Macros FAQ
  • Content: For variable IUPACNAM, IUPAC is a not a recognized content for Controlled Terms, Codelist, or Format
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