Introduction

The Tobacco Implementation Guide (TIG) Version 1.0 TOBA-91 - Getting issue details... STATUS 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 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 FDA-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 cigarettes, 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.