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Guidance in this section describes how to implement CDISC standards for the collection, representation, and exchange of tobacco product study data and focuses on implementation for use cases inherent to studies of tobacco products. Use cases included 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 this guide:

Use Case Concepts
Product Description

Data used to characterize a product.

Trial DesignData to describe the overall plan and design of a study.
NonclinicalData used to assess products from in vitro and in vivo nonclinical studies.
Product Impact on Individual HealthData used to assess the impact on of a product on individuals.  
Product Impact on Population HealthData used to assess the impact of a product on a population of individuals.

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