| Notes to Readers | 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. - CDASH Model v1.2
- SDTM v2.1
- ADaM v2.1
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.
|
|---|