Introduction

The Tobacco Implementation Guide Version 1.0 (TIG v1.0) has been prepared by the Tobacco Implementation Guide Team of the Clinical Data Interchange Standards Consortium (CDISC) with support from the U.S. Food and Drug Administration Center for Tobacco Products (FDA 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 and all products deemed to be a tobacco product, such as:

• Cigarettes
• Electronic nicotine delivery systems (ENDS; vapes)
• Roll-your-own tobacco products
• Smokeless tobacco products
• Cigars
• Pipe tobacco products
• Waterpipe tobacco products
• Heated tobacco products (HTPs)

Requirements for data submission to FDA CTP are defined and managed by FDA CTP and are out of scope for this guide. Tobacco products listed above are for example purposes only. Users of this guide should refer to FDA CTP guidance for products regulated by the agency and for related submission requirements (available at https://www.fda.gov/tobacco-products).