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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). The TIG v1.0 addresses concepts and endpoints for studies of tobacco products and translates them into CDISC standards to improve semantic understanding, support data sharing, and facilitate global regulatory applications. This implementation guide describes how to use CDISC standards for tobacco product studies and is intended to guide purpose of the TIG is to guide the use of CDISC standards for the organization, structure, and format of standard data collection, data tabulation, and analysis data tobacco product data submitted to a regulatory authority.

This guide applies to products regulated by the U.S. Food & Drug Administration (FDA) Center for Tobacco Products (CTP), including synthetic nicotine as well as products deemed to be a tobacco product including electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels. Requirements for data submission to FDA-CTP are defined and managed by FDA-CTP and are out of scope for this guide.

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The TIG provides guidance for the

• collection of study data with case report forms (CRFs) using the Clinical Data Acquisition Standards Harmonization (CDASH) model,
• tabulation of study data using the Study Data Tabulation Model (SDTM), and
• creation of analysis datasets using the Analysis Data Model (ADaM), with
• references to additional CDISC standards and resources to support implementation.

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 of implementation of these standards for specific use cases are also provided to illustrate the intended use of each standardstandards.