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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) with support from the U.S. Food & and Drug Administration (FDA) Center for Tobacco Products (CTP) using the CDISC standards development process. The TIG This document is a CDISC Foundational foundational standard that is a single, stand-alone, comprehensive implementation guide for tobacco product data submissions.

This document provides guidance for

Collection

• 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.