Introduction

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). In funding from FDA CTP. 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 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.