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DOMAINSTUDYIDSPTOBIDINGCMPIDIQCATIQPARENTIQLEVELIQFUNCTIQTARGIQMINIQMAXIQUNIT

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 AbbreviationCharIQIdentifierTwo-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
IQPARENT

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
IQLEVEL

Grade

Char
Record QualifierThe grade of the ingredient represented in INGCMPID (e.g., "FOOD")
IQFUNCT

Purity

Char
Record QualifierThe purity of the ingredient represented in INGCMPID (e.g., "99%", ">99%").
IQVALTRGDesign Parameter Element Target ValueChar*Result QualifierTarget value, according to the manufacturer's design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID.Req
IQVALMIN

Design Parameter Element Minimum Value

Char
Result QualifierMinimum allowable value, according to the manufacturer's design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID.Exp
IQVALMAX

Design Parameter Element Maximum Value

Char
Result QualifierMaximum allowable value, according to the manufacturer's design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID.Exp
IQVALUDesign Parameter Element Value UnitChar(UNIT)Result QualifierThe single unit for the values in IQVALTRG, IQVALMIN and IQVALMAX. Will be blank for unitless parameters (e.g., "Number of Heating Elements"). Must be used where applicable (e.g., "Circumference").Perm

Metadata Checks Findings

SDTMIG v3.3 Metadata Check User Macros FAQ
  • Content: For variable IQLEVEL, CDISC Notes does not have an ending period
  • Content: For variable IQLEVEL, a value is missing in Core
  • Content: For variable IQFUNCT, 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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