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.
- How to represent tobacco product identifiers and descriptors
- How to represent product design parameter specifications, and testing for conformance to those specifications.
- How to represent and quantify tobacco ingredients, non-tobacco ingredients, and additives.
- How to represent tobacco product testing for HPHC content.
- How to represent stability study data data.
- 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 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.
Overview
Content Tools