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• Collection of study data using the Clinical Data Acquisition Standards Harmonization (CDASH) model;
• Tabulation of collected data using the Study Data Tabulation Model (SDTM); and
• Creation of analysis datasets using the Analysis Data Model (ADaM)

Additionally, the The TIG provides examples for use cases inherent to tobacco product studies to demonstrate and support understanding of intended use of these standards.

Additionally, the TIG references... which may be used with standards in this guide...