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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 AbbreviationCharITIdentifierTwo-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
IGDCMPIDIngredient or Component IdentifierChar
IdentifierIdentifier given to an ingredient, substance or component of a tobacco product. In IT, it must be a tobacco ingredient of the product represented in SPTOBID (e.g., "Burley Tobacco", "Reconstituted Tobacco").Req
TPMF

Tobacco Product Master File ID

Char
IdentifierThe Tobacco Product Master File number, if applicable.Perm
ITSPECIFSpecification or Variety of Tobacco IngrChar
Variable QualifierA qualifier of IGDCMPID. Used to represent the specification (variety) of tobacco ingredient (e.g., "USDA Nicotiana Collection PI 552747", "KT215LC").Exp
ITIGDPLXIngredient ComplexityChar(IGDCMPLX)Grouping QualifierUsed to denote whether a tobacco ingredient is a single or complex ingredient (e.g., "SINGLE INGREDIENT", "COMPLEX INGREDIENT")Exp
ITCIGIND

Applicant-Customized Ingredient Indic

Char(NY)Record QualifierUsed to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where ITIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N".Perm
ITCURMTHCure MethodChar*Record QualifierMethod by which the tobacco ingredient is cured (e.g., "Air", "Sun", "Flue").Exp

Metadata Checks Findings

SDTMIG v3.3 Metadata Check User Macros FAQ
  • Content: For variable ITIGDPLX, codelist IGDCMPLX is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
  • Content: For variable ITIGDPLX, CDISC Notes does not have an ending period

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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