| Notes to Readers | The Tobacco Implementation Guide Version 1.0 has been prepared by the Tobacco Implementation Guide team of the Clinical Data Interchange Standards Consortium (CDISC) with support from the US 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 study data with case report forms using the Clinical Data Acquisition Standards Harmonization Model (Version 1.2),
- tabulation of study 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.
|
|---|