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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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The Food and Drug Administration is announcing the availability of a cooperative agreement for the development of data standards and terminology standards to support tobacco product development and evaluation.  The primary objective is to support the development of non-proprietary, consensus-based data standards for use in studies, scientific review, and post-market surveillance of tobacco products.  

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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), 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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