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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. Implementation guidance in this section addresses use cases for data inherent to studies of tobacco products. Use cases selected are comprised of concepts identified by one or more stakeholders as important in the context of tobacco product studies in the following categories:


Use Case Description
Product Description

Data used to characterize a product.

Trial DesignData which describes the overall plan and design of a study.
NonclinicalData 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.

Implementation guidance is organized in the following subsections:

Finalize when all sections are drafted.

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