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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 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, available at https://www.cdisc.org/standards/foundational/sdtm), which describes the general conceptual model for representing clinical study data that is submitted to regulatory authorities and should be read prior to reading the SDTMIG. SDTMIG Version 3.4 provides specific domain models, assumptions, business rules, and examples for preparing standard tabulation datasets that are based on the SDTM.This document is intended for companies and individuals involved in the collection, preparation, and analysis of clinical data that will be submitted to regulatory authorities.