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 & Drug Administration (FDA) Center for Tobacco Products (CTP) using the CDISC standards development process.The TIG is a CDISC Foundational standard that is a single, stand-alone, comprehensive implementation guide for tobacco product data submissions.
The TIG provides guidance for the:
Collection of study data with case report forms (CRFs) using the Clinical Data Acquisition Standards Harmonization (CDASH) v1.2 model,
Tabulation of study data using the Study Data Tabulation Model (SDTM) v2.1,
Creation of analysis datasets using the Analysis Data Model (ADaM) v2.1, with
References to additional CDISC standards and resources to support implementation.