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This section describes how to use CDISC standards for the collection and representation of tobacco product study data. Standards address use cases 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 can be grouped in the following general categories:

  • Product Description, for use cases data which characterize a product.
  • Trial Design, for standards data which describe the design of a study
  • Nonclinical, for both data from in vitro and in vivo nonclinical study use casesstudies
  • Product Impact on Individual Health, for use cases data to assess the impact on of a product on individuals  
  • Product Impact on Population Health, for use cases data to assess the impact of a product on a population of individuals

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