| Variable Name | Variable Label | Type | Controlled Terms, Codelist or Format1 | 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 | 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 |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-181 |
|---|
|
| 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 |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-182 |
|---|
|
| Perm |
| TPMF | 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. | Exp |
| IUPACNAM | Preferred IUPAC Name | Char | IUPAC | 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 | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-183 |
|---|
|
| Char | CAS | Identifier | The Chemical Abstract Service (CAS) registry number for the ingredient 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. | PermExp |
| 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 |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-96 |
|---|
|
| Record Qualifier | The grade of the ingredient represented in IGDCMPID (e.g., "FOOD") | Exp |
| INPURITY | Ingredient Purity | Char |
| Record Qualifier | The purity of the ingredient represented in IGDCMPID (e.g., "99%", ">99%"). | Exp |