This section illustrates how to use CDISC standards to represent various aspects of the identification, descriptive characteristics, product design, and testing of tobacco products that occur separately from product testing in human subjects. The concepts illustrated in the examples include:
- How to uniquely identify a tobacco product under study, or a predicate/comparator product using the Applicant-defined Tobacco Product Identifier (SPTOBID) variable, which is used in any applicable dataset throughout the product development lifecycle to identify the tobacco product that is a focal point of a record. or records
- 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.
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 also be aware that the examples included here do not necessarily show exhaustive lists of the various tests and parameters that would be required for the tobacco products that are illustrated. 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.
The Tobacco Product Identifiers and Descriptors example is applicable to ALL studies of tobacco products. Users should review this example first before skipping ahead to other examples.
The variable PTCAT (Category of Test) in the Product Testing (PT) domain is a required variable (and therefore must be populated in submitted PT datasets). This variable will be necessary to group and differentiate records coming from the many types of tests that are represented in this domain, some of which will contain the same analytes collected under different contexts. The use of PTCAT makes the context of the analyte data collection explicit.
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