The purpose of the TIG is to guide the use of CDISC standards for the organization, structure, and format of tobacco product study data submitted to a regulatory authority. The TIG provides guidance for the:
- Collection of study data using the Clinical Data Acquisition Standards Harmonization (CDASH) model;
- Tabulation of study data using the Study Data Tabulation Model (SDTM);
- Creation of analysis datasets using the Analysis Data Model (ADaM); with
- References to the Operational Data Model (ODM-XML) and Define-XML standards and resources to support the exchange of structured data between parties and across different information systems.
The TIG also provides examples for use cases inherent to tobacco product studies to demonstrate and support understanding of the intended use of these standards.
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