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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 Format1RoleCDISC 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
INMANUINManufacturer Unique Identifying Item NumChar
IdentifierThe unique identifying item number assigned by the manufacturer to the ingredient or component shown in IGDCMPID (e.g, catalog number).Perm
INMANUFN

Manufacturer Registration Number TOBA-181 - Getting issue details... STATUS

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. TOBA-182 - Getting issue details... STATUS

Perm
TPMF

Tobacco Product Master File Number

Char
IdentifierThe Tobacco Product Master File number for the ingredient/component represented in IGDCMPID, if applicable.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. Expected to be populated where INIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N".Perm
INGRADE

Ingredient Grade

Char

TOBA-96 - Getting issue details... STATUS

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

Ingredient Purity

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

Metadata Checks Findings

Metadata Check User Macros FAQ
  • Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (expected)
  • Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>
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