The TIG provides examples to demonstrate the intended use of CDISC standards for tobacco product studies and to support further understanding of implementation guidance in Section 2, Standards for Tobacco Product Studies. The examples in this guide reflect use cases for data inherent to studies of tobacco products. Use cases selected present concepts identified by one or more stakeholders as important in the context of tobacco product studies and are organized in the following sections:
- Product Description, for use cases which characterize a product
- Trial Design, for standards which describe the design of a study
- Nonclinical, for nonclinical study use cases
- Product Impact on Individual Health, for use cases to assess the impact on of a product on individuals
- Product Impact on Population Health, for use cases to assess the impact of a product on a population of individuals
Examples in this guide are intended to show collection and/or representation of data using CDISC standards and are not intended to influence decisions regarding what data to collect or represent. For guidance on the selection of data to collect or represent, please refer to the appropriate regulatory authority.
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