TIG sections

The Tobacco Implementation Guide Version 1.0 has been prepared with support from the U.S. Food and Drug Administration Center for Tobacco Products using the CDISC standards development process. This document is a CDISC foundational standard that is a single, stand-alone, comprehensive implementation guide for tobacco product data submissions.

This document provides guidance for

• collection of data with case report forms using the Clinical Data Acquisition Standards Harmonization Model (Version 1.2),
• tabulation of data using the Study Data Tabulation Model (Version 2.1), and
• creation of analysis datasets using the Analysis Data Model (Version 2.1), with
• references to additional CDISC standards and resources to support implementation.