Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
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STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | 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 |
| 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 | INMANUFN | Manufacturer Registration Number Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-181 |
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|
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INMANUIN | Manufacturer Unique Identifying Item Num | 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. Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-182 |
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| unique identifying item number assigned by the manufacturer to the ingredient or component shown in IGDCMPID (e.g, catalog number). | Perm |
| Tobacco Product Master File Number | Char |
| Identifier | The Tobacco Product Master File number for the ingredient/component represented in IGDCMPID, if applicable. | Perm | UNII | Unique Ingredient Identifier | Char | UNII | Identifier | The FDA Unique Ingredient Identifier (UNII) number for the ingredient represented in IGDCMPID. | 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. | PermExp |
IUPACNAM | Preferred IUPAC Name | Char | | Identifier | The preferred International Union of Pure and Applied Chemistry (IUPAC) name of the ingredient represented in IGDCMPID, if applicable. | Exp |
CASNO | | Char | showSummaryCAS false | server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-183 |
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| Char | CAS | Identifier | Identifier | The Chemical Abstract Service (CAS) registry number for the ingredient represented in IGDCMPID. | Perm |
| Unique Ingredient Identifier | Char | UNII | Identifier | The FDA Unique Ingredient Identifier (UNII) The Chemical Abstract Service (CAS) registry number for the ingredient represented in IGDCMPID, if applicable. | ExpPerm |
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. Expected to be populated where INIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N". | Perm |
INGRADE | Ingredient Grade | Char | Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-96 |
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| | Record Qualifier | The grade of the ingredient represented in IGDCMPID (e.g., "USP", "FOOD"). | Exp |
INPURITY | Ingredient Purity | 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 |