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The TIG provides examples to demonstrate the intended use of CDISC standards for tobacco product data and to support further understanding of implementation guidance in Section 2, Standards for Tobacco Product Data. 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:

• Section 3.1, Product Description
• Section 3.2, Nonclinical
• Section 3.3, Product Impact on Individual Health
• Section 3.4, Product Impact on Population Health

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

DRAFT

To reiterate: It is important to note that the choice of biomedical concepts included in this user guide is not intended to influence sponsor decisions regarding what data to collect. The examples included are intended to show how particular kinds of data can be represented using CDISC standards. This user guide emphasizes that examples are only examples and should not be over-interpreted. For guidance on the selection of biomedical concepts and endpointsdata to collect or represent, please refer to the appropriate clinical and regulatory authoritiesauthorites.