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). The TIG v1.0 addresses concepts and endpoints for studies of tobacco products and translates them into CDISC standards to improve semantic understanding, support data sharing, and facilitate global regulatory applications. This implementation guide describes how to use CDISC standards for tobacco product studies and is intended to guide the organization, structure, and format of standard data collection, data tabulation, and analysis data submitted to a regulatory authority.
This guide applies to products regulated by the U.S. Food & Drug Administration (FDA) Center for Tobacco Products (CTP), including synthetic nicotine as well as products deemed to be a tobacco product including electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels. Requirements for data submission to FDA-CTP are defined and maintained by FDA-CTP and are out of scope for this guide.
Provided in this guide are advice and examples for the Clinical Data Acquisition Standards Harmonization (CDASH) model, the Study Data Tabulation Model (SDTM), and the Analysis Data Model (ADaM), including
guidance on the use of domains and variables; and
sample annotated case report forms (aCRFs);
- examples of SEND and SDTM datasets, with text describing the situational context and pointing out records of note; and
- guidance on the use of ADaM and other analysis datasets
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