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This section describes how to use implement CDISC standards for the collection, representation, and representation exchange of tobacco product study data. Standards addressdata 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 can be grouped in the following general categoriesresearch.

The following use cases are specifically addressed in the TIG:

  • Product Descriptiondescription, for use cases which characterize a product.
  • Trial Design, for standards which describe the design of a study
  • 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 Nonclinical, for both in vitro and in vivo nonclinical study use casesstudies
  • Product Impact impact on Individual Health, for use cases 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 use cases population health, which refers to concepts used to assess the impact of a product on a population of individuals

Guidance is organized in the following sections:

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