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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2
Metadata check macro is applied. Make sure all Confluence WIKI macros e.g., JIRA, Status, are removed prior to publication. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|---|---|---|---|---|---|
| STUDYID | Study Identifier | Char | Identifier | Unique identifier for a study. | Req | |
| DOMAIN | Domain Abbreviation | Char | IN | Identifier | Two-character abbreviation for the domain. | Req |
| SPTOBID | Applicant-Defined Tobacco Product ID | Char | Identifier | Identifier 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 | |
IGDCMPID TOBA-743 - Getting issue details... STATUS | Ingredient or Component Identifier | Char | Identifier | Identifier 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 | |
| INMANUF | Manufacturer Name | Char | Identifier | The 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 TOBA-742 - Getting issue details... STATUS | 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 | |
| IUPACNAM | Preferred IUPAC Name | Char | IUPAC Nomenclature TOBA-744 - Getting issue details... STATUS | Identifier | The 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 | Char | CAS TOBA-745 - Getting issue details... STATUS | Identifier | The Chemical Abstract Service (CAS) registry number for the ingredient represented in IGDCMPID. | Perm |
UNII TOBA-746 - Getting issue details... STATUS | Unique Ingredient Identifier | Char | UNII | Identifier | The FDA Unique Ingredient Identifier (UNII) number for the ingredient represented in IGDCMPID. | Perm |
| INIGDPLX | Ingredient Complexity | Char | (IGDCMPLX) | Grouping Qualifier | Used 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 Qualifier | Used 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 Qualifier | The grade of the ingredient represented in IGDCMPID (e.g., "USP", "FOOD"). | Exp |
| INPURITY | Ingredient Purity TOBA-317 - Getting issue details... STATUS | Char | Record Qualifier | The purity of the ingredient represented in IGDCMPID, provided for any ingredient for which this information is available (e.g., "99%", ">99%"). | Exp |
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