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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. Standards Implementation of standards described in this guide support use cases 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 general four categories:


Metadataspec
CategoryDescription
Product Description
  1. Product Description, for data which characterize a product.
  2. Trial Design, for data which describe the design of a study
  3. Nonclinical, for data from in vitro and in vivo nonclinical studies
  4. Product Impact on Individual Health, for data to assess the impact on of a product on individuals  
  5. Product Impact on Population Health, for data to assess the impact of a product on a population of individuals
Trail Design
Nonclinical
Product Impact on Individual Health
Product Impact on Population Health











Guidance in this section is organized in the following sections:

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