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  • How to uniquely identify a tobacco product under study, or a predicate/comparator product using the Sponsor-defined Tobacco Product Identifier (SPTOBID) variable, which can used in any applicable datasets throughout the product development lifecycle to identify the tobacco product that is a focal point of the record on which it is used.
  • How to represent tobacco product identifying and descriptive parameters using the Tobacco Product Identifiers and Descriptors (TO) domain.
  • How to represent product design parameter specifications using the Product Design Parameters (PD) domain, and the results of testing for conformance to those specifications using the Tobacco Product Testing (PT) domain.
  • How to represent and quantify tobacco ingredients, non-tobacco ingredients, and additives using the Tobacco Ingredients (IT) domain, the Non-Tobacco Ingredients (IN) domain, and the Ingredient Quantities by Component (IQ) domain.
  • How to represent tobacco product testing for HPHC content using the Tobacco Product Testing (PT) domain.
  • How to represent smoking machines and smoking regimens using the Device Identifiers (DI) domain, and the Device In-Use Properties (DU) domain, and how to relate those to measurements of analytes using the DURERFID and PTREFID variables.
  • How to represent stability study results using the Tobacco Product Testing (PT) domain..
  • How to represent storage conditions used in stability studies using the Environmental Storage Conditions (ES) domain, and how to relate the parameters of those conditions to the stability study results using the STOCONID variable.
Info

The examples in this section do not illustrate the various concepts described above for all categories and subcategories of tobacco products. Concepts are illustrated primarily using cigarettes, ENDS devices, and/or smokeless tobacco products. The data modeling of the concepts illustrated would work the same for all other tobacco product categories as well (i.e, the same datasets and variables would be used the same way as illustrated in the examples shown).

Users of this guide should be aware that additional terminology to support creation of CDISC-conformant datasets representing the various parameters and analytes applicable to all tobacco products will be developed in an ongoing basis independent of the publication of this guide. For more information on controlled terminology see How to Use Controlled Terminology and Formats.

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