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This section describes how to implement CDISC standards for the collection, representation, and exchange of tobacco product study data. Implementation of standards described in this section support 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 and fall in the following four categories:


Metadataspec
CategoryDescription
Product Description

Data to characterize a product.

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











Guidance in this section is organized in the following sections:

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