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This section describes how to implement CDISC standards for the collection, representation, and exchange of tobacco product data with focus on implementation for use cases inherent to tobacco product data. Use cases in this guide comprise concepts identified by 1 or more stakeholders as important in the context of tobacco product research.

The following use cases are specifically addressed in the TIG:

• Product description, 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

An introduction to standards in TIG and how they interact

Data collection and Data Tabulation standards have been developed in this guide and are described in Section X ????.  These standards are based on the SDTM Model. The SDTM model has been designed to represent the broadest range of human and animal study data in a standardized manner.  This SDTM Model document  ( REF ) describes the basic concepts and general structure of the model. Individual implementation guides (IGs) have also been created to provide detail specification and recommendations for representing  data commonly collected. The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) https://www.cdisc.org/standards/foundational/sdtmig provides useful guidelines for creating data tabulations for Human Clinical Trials. Since, data tabulations and clinical study reports on tobacco products are operationally similar to data tabulations and clinical study reports prepared for Human Clinical Trials, the SDTMIG was employed in developing this section.  

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