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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. |
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The variable PTCAT (Category of Test) in the Product Testing (PT) domain is an expected variable (and therefore should be included). This variable will be necessary to group and differentiate records coming from the many types of tests that are represented in this domain. |
The examples in this section illustrate 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. These examples demonstrate concepts including:
- How to uniquely identify a tobacco product under study 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 stability study results using the Tobacco Product Testing (PT) domain.
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