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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 Version 1.0 provides specific domain models, assumptions, business rules, and examples for preparing standard data collection, tabulation datasets, and analysis datasets that are based on the CDASH, SDTM, ADaM, and Analysis Results models respectively. This document is intended for companies and individuals involved in the collection, preparation, and analysis of product description, non-clinical, and clinical data that will be submitted to regulatory authorities. The TIG should be used in close concert with:provides guidance for the

• collection of study data with case report forms (CRFs) using the Version 1.2 of the CDISC Clinical Data Acquisition Standards Harmonization (CDASH, available at https://www.cdisc.org/standards/foundational/cdash/cdash-model-v1-2) , provides a general framework for creating fields to collect information on CRFs and includes the model metadata, which shows the standard variables in the model.Version 2.0 of the CDISC
• tabulation of study data using the Study Data Tabulation Model (SDTM, 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
• creation of analysis datasets using the Version 2.1 of the CDISC Analysis Data Model (ADaM, avalible at ), which describes...Version TBD of the Analysis Results Model... 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.