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The purpose of this implementation guide the TIG is to describe how to guide use of CDISC standards for tobacco product studies for the organization, structure, and format of standard data collection, data tabulation, and analysis data tobacco product study data submitted to a regulatory authority. Guidance for The TIG provides guidance for the:

• Collection of study data using the Clinical Data Acquisition Standards Harmonization (CDASH) model

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• ;
• Tabulation of collected data using the Study Data Tabulation Model (SDTM)

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• ; and
• Creation of analysis datasets using the Analysis Data Model (ADaM)

The TIG also provides examples for use cases inherent to tobacco product studies to demonstrate and support understanding of for collection and representation of tobacco product study data are provided in this guide. Examples are also provided to demonstrate the intended use of these standards for tobacco product studies.