Page History

The IT example below shows 4 types of tobacco listed as tobacco ingredients (STRFID) for the Tobacco Product The following examples illustrate how the list of ingredients of a tobacco product would be represented and quantified using three datasets:

• Tobacco Ingredients (IT) is used for representing the tobacco ingredients and their attributes within the tobacco product under study.
• Non-tobacco Ingredients (IN) is used for representing other ingredients/additives and their attributes as used in the tobacco product under study.
• Ingredients Quantified (IQ) is used for representing the quantity of each ingredient (both tobacco and non-tobacco) by component of the tobacco product in which they are included. These values represent the design/formulation specification of the product, not experimentally determined values (as the latter would be represented in the Product Testing (PT) dataset, not shown here). (see note 1 – need to confirm this is true)

All three datasets make use of the SPTOBID variable to identify the tobacco product under study, and the STRFID (Substance Reference Identifier) variable to represent the ingredient name. STRFID must be assigned by study sponsors to be unique with regard to the attributes that describe it. If, for instance, the same ingredient varies on one or more attribute (e.g., two different manufacturers supplied the same ingredient, each with different purities, that is used in two different components of the product ), STRFID must be unique for each use to reflect this difference, even if they share the same common name, IUPAC name and CAS number. (see note 5)

IT example shows tobacco filler and the types of tobacco of which it is composed, each listed as tobacco ingredients in the variable IGDCMPID (ingredient or component identifier) for the tobacco product CIG01A (SPTOBID). The variable ITSPECIF shows the specification (/variety ) of the first three 3 tobaccos. ITCAT ITIGDPLX (Ingredient Complexity) is used to indicate that Reconstituted Tobacco is a complex, purchased ingredientthe tobacco filler and the reconstituted tobacco are complex ingredients (i.e., have 2 or more subcomponents). The details of which single tobacco ingredients compose these complex ingredients is made explicit in the IQ dataset example. ITCURMTH indicates the cure method. ITCPISP ITCIGIND (applicant-customized ingredient indicator) is used to indicate whether complex purchased ingredients were made to the applicant's specification. TMRF TPMF indicates the Tobacco Master Reference File. (See note 2)Product Master File name/number, which should be provided in the data if the component manufacturer has made it available.
Note that there are 2 varieties of burley tobacco in this tobacco product; each is given a unique IGDCMPID value (Burley Tobacco and Burley Tobacco 2).

The IN dataset example below shows the list of non-tobacco ingredients used in the tobacco product identified as CIG01A. Each unique ingredient is listed in STRFIDIGDCMPID. Where applicable, IUPAC name and CAS number are listed (IUPACNAM and CASNO variables, respectively). INCAT INIGDPLX is used to indicate whether an ingredient is a single chemical substance ingredient or a complex purchased ingredient. INSPFL indicates  INCIGIND  indicates whether complex purchased ingredients were made to the applicant's specification. Grade, purity, manufacturer name and ID , ingredient unique item number, and the Tobacco Master Reference File number 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 STRFID 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. Note: Ingredients that appear in more than one 1 component of the tobacco product are quantified separately for each component. (see note 3) IQPARENT and IQLEVEL are used to identify the component/ingredient of which the ingredient in a record is a constituent component, and and at which level in the overall hierarchy the constituent ingredient appears. The following implementation rules applyIQPARENT identifies a component or complex ingredient composed of the subcomponents/ingredients shown in IDGCMPID. IQLEVEL is used to identify at what level in the overall hierarchy that subcomponent/ingredient appears.

The following implementation rules apply, as described in more detail in Section 2.8.8.6, SDTM Ingredient Quantities by Component (IQ), Assumptions:

• IQPARENT must correspond to a value of STRFID IGDCMPID in the same dataset. If  If parent is null, the ingredient is considered a top-level component and is assigned a an IQLEVEL value of "1" in IQLEVEL.
• Records describing subcomponents/ingredients that are constituent ingredients of another ingredient/compose a parent component listed in the dataset will have IQPARENT value equal to the STRFID IGDCMPID of that ingredient/parent component. IQLEVEL will be set to n +1, where n = the parent record's value of IQLEVEL.
• Every value of STRFID IGDCMPID used in the IQ dataset that has an IQLEVEL >1 (See note 4) must have a matching value of STRFID in eitherIGDCMPID:
  • The In the IT dataset (when IQCAT=TOBACCO INGREDIENT), or,
  • The In the IN dataset (when IQCAT=NON-TOBACCO INGREDIENT)

Therefore, IQCAT is required to relate ingredient quantity records in IQ to the associated ingredient attributes described in either IT or IN.

The concept map below use of IQPARENT and IQLEVEL help make explicit the relationship between complex ingredients or components and the subcomponents/ingredients of which they are composed, and can assist when totaling the quantities of an ingredient that appears in multiple components of a tobacco product.
 
This concept map illustrates the representation of the hierarchical relationships between a complex ingredient component and its constituent subcomponents/ingredients in the IQ domain structure. The hypothetical parent ingredient has two constituent components, A and B. Additionally, B consists of two constituent components, B1 and B2. Therefore, there are a total of 5 ingredient records to be represented in the IQ domain: the parent ingredient, its two constituent components A and B, and B's two constituent components, B1 and B2.
 

Image Removed

The IQ dataset example illustrates the these principles discussed above , using a cigarette tobacco product: