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 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 data which describe product attributes
- Trial Design, for data which describes the design of a study
- Nonclinical, for data collected as part of nonclinical of a nonclinical study
- Product Impact on Individual Health, for data collected to assess a product's impact on individuals
- Product Impact on Population Health, for data collected to assess a product's impact on populations 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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