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Guidance in this This section describes how to implement CDISC standards for the collection, representation, and exchange of tobacco product study data. Standards in this guide support use data with focus on implementation for use cases inherent to studies of tobacco productsproduct data. Use cases selected are comprised of in this guide comprise concepts identified by one 1 or more stakeholders as important in the context of tobacco product studies and fall in the following general categoriesresearch.

The following use cases are specifically addressed in the TIG:

  • Product Descriptiondescription, for data which characterize a product.
  • Trial Design, for data which describe the design of a study
  • 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 Nonclinical, for data from in vitro and in vivo nonclinical studies
  • Product Impact impact on Individual Health, for data individual health, which refers to concepts used to assess the impact on of a product tobacco products on individuals  individuals
  • Product Impact impact on Population Health, for data population health, which refers to concepts used to assess the impact of a product on a population of individuals

Guidance in this section is organized in the following sections:

Finalize when all sections are drafted.

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