Purpose

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 the organization, structure, and format of standard data collection, data tabulation, and analysis 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.

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 for use cases inherent to studies of tobacco products are also provided to illustrate the intended use of each standard.