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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 AbbreviationCharIQIdentifierTwo-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
Identifier

Identifier given to an ingredient, substance or component of a tobacco product represented in SPTOBID. In IQ, it must match a value of IGDCMPID in either the IT dataset (if the ingredient is a tobacco ingredient) or IN (if the ingredient is a non-tobacco ingredient).

(e.g., "Burley Tobacco", "Propylene Glycol", "Cocoa Extract", "Cellulose Pulp").

Req
IQIGDPLXIngredient ComplexityChar(IGDCMPLX)Grouping QualifierUsed to denote whether a ingredient is a single or complex ingredient (e.g., "SINGLE INGREDIENT", "COMPLEX INGREDIENT")Exp

IQPARENT TOBA-237 - Getting issue details... STATUS

Parent of Ingredient or Component

Char
Record QualifierIdentifies the parent of which the ingredient or component represented in IGDCMPID is a constituent. (i.e, IGDCMPID is a child of the ingredient shown in IQPARENT). IQPARENT must equal a value of IGDCMPID from another record in the same dataset. If the ingredient is at the top level (i.e., it has no parent other than the tobacco product itself), IQPARENT will be null and IQLEVEL will be set to 1. (See IQLEVEL, below).Perm
IQLEVEL

Ingredient Level in Hierarchy

Num
Record QualifierAn integer that identifies the level of the ingredient or constituent within the hierarchy. The value of IQLEVEL will be n+1, where n is the IQLEVEL of the parent ingredient. IQLEVEL will be set to 1 If the ingredient is at the top level (i.e., if the ingredient has no parent ingredient/component other than the tobacco product itself). Must be populated when IQPARENT is populated.Req
IQFUNCT

Ingredient Function

Char
Record QualifierThe function of the ingredient in the tobacco product or the parent component. (e.g., "Adhesive", "Flavorant").Exp
IQVALTRGIngredient Target ValueNum
Result QualifierTarget value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALTRG represents the target quantity within the parent component, not the overall quantity in the tobacco product.Req
IQVALMIN

Ingredient Minimum Value

Num
Result QualifierMinimum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMIN represents the minimum quantity within the parent component.Exp
IQVALMAX

Ingredient Maximum Value

Num
Result QualifierMaximum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMAX represents the maximum quantity within the parent component.Exp
IQVALUIngredient Value UnitChar(UNIT)Result QualifierThe single unit for the values in IQVALTRG, IQVALMIN and IQVALMAX.Exp

Metadata Checks Findings

Metadata Check User Macros FAQ
  • Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format (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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