The purpose of this implementation guide is to describe how to use CDISC standards for tobacco product studies for the organization, structure, and format of standard data collection, data tabulation, and analysis data submitted to a regulatory authority. Guidance for using the Clinical Data Acquisition Standards Harmonization (CDASH) model, the Study Data Tabulation Model (SDTM), and the Analysis Data Model (ADaM) 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.
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