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This webinar will provide an overview of the Tobacco Implementation Guide (v1.0) to support Public Review for this standard.
Developed in partnership with the FDA’s Center for Tobacco Products (CTP), the TIG v1.0 is a Foundational Standard that serves as a comprehensive resource for the collection, tabulation, analysis, and exchange of tobacco product data for submissions to FDA-CTP. The TIG v1.0 implements the CDASH Model v1.2, SDTM v2.1 and ADaM v2.1, with references to standards such as the Define-XML v2.1, to standardize data for submission and facilitate tobacco product research, scientific review, and harm reduction. The TIG v1.0 focuses on implementation for use cases inherent to tobacco product data composed of concepts identified by one or more stakeholders as important in the context of tobacco product research.
Presenters
- Christine Connolly, Head of Standards Projects, CDISC