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:
- CDISC eCRF Portal and related Operational Data Model (ODM-XML) standards
- Define-XML standards and resources to support the exchange of structured data between parties and across different information systems.
- CORE
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.
Overview
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