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The TIG provides guidance for how to use CDISC standards for the collection and representation of tobacco product study data. Standards in this guide are applied applicable to use cases inherent to studies of tobacco products. Use cases represent selected are comprised of concepts identified by one or more stakeholders as important in the context of tobacco product studies . Use cases covered in this guide are organized in the following categories:

• Product Description, for use cases which characterize a product
• Trial Design, for standards which describe the design of a study
• Nonclinical, for both in vitro and in vivo 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

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Introduction text needed

• guidance on the use of domains and variables; and
• sample annotated case report forms (aCRFs);
• examples of SEND and SDTM datasets, with text describing the situational context and pointing out records of note; and
• guidance on the use of ADaM and other analysis datasets