1.0 Release Date: 10 June 2024
Developed in partnership with the U.S. Food and Drug Administration Center for Tobacco Products (FDA CTP), the Tobacco Implementation Guide (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.
Use cases addressed in the TIG v1.0 include:
- Product Description, which refers to concepts used to characterize tobacco products.
- Nonclinical, which refers to concepts used to identify potential risks and effects on biological processes for tobacco products via in vitro and in vivo nonclinical studies.
- Product Impact on Individual Health, which refers to concepts used to assess the impact of tobacco products on individuals.
- Product Impact on Population Health, which refers to concepts used to assess the impact of tobacco products on populations of individuals.
The TIG Conformance Rules Version 1.0 supports consistent implementation of TIG v1.0 standards.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.