The IT example| 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-310 |
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below shows tobacco filler and the types of tobacco of which it is composed, each listed listed as tobacco ingredients (IGDCMPIDin the variable IGDCMPID (ingredient or component identifier) for the Tobacco Product CIG01A (SPTOBID). The variable ITSPECIF shows the specification (/variety ) of the first three tobaccos. ITIGDPLX (Ingredient Complexity) is used to indicate that the Tobacco Filler and the Reconstituted Tobacco are complex ingredients (they both have two or more subcomponents). The details of which single tobacco ingredients compose these complex ingredients is made explicit in the IQ dataset example further down. ITCURMTH indicates the cure method. ITSPFL ITCIGIND (applicant-customized ingredient indicator) is used to indicate whether complex ingredients were made to the applicant's specification. TPMF indicates the Tobacco Product Master File name/number, which should be provided in the data if the component manufacturer has made it available.| 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-307 |
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Note that there are two varieties of burley tobacco in this tobacco product, thus each is given a unique IGDCMPID value (Burley Tobacco and Burley Tobacco 2).
| Dataset wrap |
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| Dataset2 |
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| | STUDYID | SPTOBID | IGDCMPID | TPMF | ITSPECIF | ITIGDPLX | ITCURMTH | ITSPFLITCIGIND |
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| 1 | IT | TOB07 | CIG01A | Tobacco Filler |
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| COMPLEX INGREDIENT |
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| 2 | IT | TOB07 | CIG01A | Burley Tobacco | MF5555555 | NC 7LC | SINGLE INGREDIENT | Air |
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| 3 | IT | TOB07 | CIG01A | Bright Tobacco |
| CC 1063 | SINGLE INGREDIENT | Flue |
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| 4 | IT | TOB07 | CIG01A | Oriental Tobacco |
| USDA Nicotiana Collection PI 552747 | SINGLE INGREDIENT | Sun |
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| 5 | IT | TOB07 | CIG01A | Reconstituted Tobacco |
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| COMPLEX INGREDIENT |
| N |
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| 6 | IT | TOB07 | CIG01A | Burley Tobacco 2 |
| KT215LC | SINGLE INGREDIENT | Air |
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The IN dataset example below shows the list of non-tobacco 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-112 |
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| 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-106 |
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used in the tobacco product identified as CIG01A. Each unique ingredient is listed in IGDCMPID
| 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-304 |
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. Where applicable, IUPAC name and CAS
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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-305 |
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number are listed (IUPACNAM and CASNO
variables, respectively). INIGDPLX is used to indicate whether an ingredient is a single ingredient or a complex ingredient.
| 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-306 |
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INCIGIND | 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-311 |
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indicates whether complex ingredients were made to the applicant's specification. Grade, purity, manufacturer name, ingredient unique item number, and the Tobacco Product Master File number complete the dataset.
...
Finally, the IQ domain is used to represent the quantity (target, minimum and maximum) of each ingredient identified in IGDCMPID that the product (SPTOBID) is designed to contain, with the units for these values represented in IQUNIT. The function of each ingredient is described in IQFUNCT. Ingredients that appear in more than one component of the tobacco product are quantified separately for each component. IQPARENT identifies a component or complex ingredient composed of the subcomponents/ingredients shown in IDGCMPID. IQLEVEL is used to identify at what level
| 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-240 |
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in the overall hierarchy that subcomponent/ingredient appears.
The following implementation rules apply
, as described in more detail under the "Assumptions" subheading in section 2.8.8.6, SDTM Ingredient Quantities by Component (IQ):
- IQPARENT must correspond to a value of IGDCMPID in the same dataset.
| 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-313 |
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If parent is null, the ingredient is considered a top-level component and is assigned an IQLEVEL value of "1". - Records describing subcomponents/ingredients that compose a parent component listed in the dataset will have IQPARENT value equal to the IGDCMPID of that parent component. IQLEVEL will be set to n +1, where n=the parent record's value of IQLEVEL
- Every value of IGDCMPID used in the IQ dataset must have a matching value of IGDCMPID:
- In the IT dataset (when IQCAT=TOBACCO INGREDIENT) or,
- In the IN dataset (when IQCAT=NON-TOBACCO INGREDIENT)
...