| Notes to Readers | The Tobacco Implementation Guide (TIG) Version 1.0 has been prepared by the Tobacco Implementation Guide team of the Clinical Data Interchange Standards Consortium (CDISC) with support from the U.S. Food & Drug Administration (FDA) Center for Tobacco Products (CTP) using the CDISC standards development process. The TIG is a CDISC Foundational standard that is a single, stand-alone, comprehensive implementation guide for tobacco product data submissions. The TIG provides guidance for the: - Collection of study data with case report forms (CRFs) using the Clinical Data Acquisition Standards Harmonization (CDASH) v1.2 model,
- Tabulation of study data using the Study Data Tabulation Model (SDTM) v2.1,
- Creation of analysis datasets using the Analysis Data Model (ADaM) v2.1, with
- References to additional CDISC standards and resources to support implementation.
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