Guidance in this section describes how to implement CDISC standards for the collection, representation, and exchange of tobacco product study data with focus on implementation for use cases inherent to studies of tobacco products. Use cases in this guide are comprised of concepts identified by one or more stakeholders as important in the context of tobacco product studies.
The following use cases are specifically addressed in the TIG:
- Product Description, which refers to concepts used to characterize tobacco products.
- Nonclinical, which refers to concepts used to identify potential risks and effects on biological processes for tobacco products via in vitro and in vivo nonclinical studies.
- Product Impact on Individual Health, which refers to concepts used to assess the impact of tobacco products on individuals.
- Product Impact on Population Health, which refers to concepts used to assess the impact of tobacco products on populations of individuals.
All tables in this section begin with column Num. Values in Num are consecutive numbers intended only to support ease of use (e.g., to allow implementers to reference rows in tables without describing row contents). Values in Num have no meaning beyond this use.
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