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The

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purpose of the TIG is to guide the use of CDISC standards for the organization, structure, and format of

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tobacco product data submitted to a regulatory authority.

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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.

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The TIG provides guidance for the

• collection of study data with case report forms (CRFs) using the Clinical Data Acquisition Standards Harmonization (CDASH) model,
• tabulation of study data using the Study Data Tabulation Model (SDTM), and
• creation of analysis datasets using the Analysis Data Model (ADaM),

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guidance on the use of domains and variables; and

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sample annotated case report forms (aCRFs);

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• with
• references to additional CDISC standards and resources to support implementation.

The TIG also provides examples for use cases inherent to tobacco product studies to demonstrate and support understanding of the intended use of standards.

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