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The TIG provides guidance for This section describes how to use implement CDISC standards for the collection, representation, and representation exchange of tobacco product study data. Standards in this guide are applied todata with focus on implementation for use cases inherent to studies of tobacco productsproduct data. Use cases represent in this guide comprise concepts identified by one 1 or more stakeholders as important in the context of tobacco product studies. Use cases covered in this guide are organized in the following categoriesresearch.

The following use cases are specifically addressed in the TIG:

• Product

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• description,

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• which refers to concepts used to characterize tobacco products
• Nonclinical, which refers to concepts used to identify potential risks and effects on biological processes for tobacco products via in vitro and in vivo nonclinical studies
• Product impact on individual health, which refers to concepts used to assess the impact of tobacco products on individuals
• Product impact on population health, which refers to concepts used to assess the impact of tobacco products on populations of individuals

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