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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 with focus on implementation for use cases inherent to studies of tobacco productsproduct data. Use cases in this guide are comprised of comprise concepts identified by one 1 or more stakeholders as important in the context of tobacco product studiesresearch.

The following use cases are specifically addressed in the TIG:

  • Product Descriptiondescription, which refers to concepts used to characterize tobacco products.
  • Nonclinical, which refers to concepts related to used to identify potential risks and effects on biological processes for tobacco products via in vitro and in vivo nonclinical studies.
  • Product Impact impact on Individual Healthindividual health, which refers to concepts used to assess the impact of tobacco products on individuals.  
  • Product Impact impact on Population Healthpopulation health, which refers to concepts used to assess the impact of tobacco products on populations of individuals.

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