Tobacco Implementation Guide v1.0 & SDTM v2.1

Comments Due By

 

CDISC is pleased to announce the Tobacco Implementation Guide (TIG) v1.0 with TIG Conformance Rules v1.0 and the SDTM v2.1 are entering the Public Review period.

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 v1.2SDTM 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 specifically 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 v1.0 and the SDTM v2.1 can be found here:

TIG v1.0

SDTM v2.1

Reviewers are requested to provide comments via JIRA. Public Review closes 18 December 2023.

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Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.

Thank you for contributing your time and expertise.