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TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 42

CDISC data standard

(1) CDISC, Austin, TX, USA; (2) Altria Client Services, Richmond, VA, USA

Clinical Data Interchange Standards Consortium (CDISC), in collaboration with the FDA’s Center for Tobacco Products (CTP), is developing non-proprietary, consensus-based data standards for tobacco product submissions, including pre-market (e.g. PMTA and SE) and 904(a) submissions. Data standards are in development by the Tobacco Implementation Guide (TIG) team, composed of members from FDA-CTP and industry, using the CDISC standards development process. Through this program, we are excited to bring application-based tobacco data standards forward with the support of FDA-CTP and believe users will benefit from a deeper understanding of this program.

In 2022, FDA sponsored a grant to create data standards for tobacco product submissions; CDISC is facilitating the development of the standards and plan to publish the TIG v1.0 in late Fall 2023. The TIG will describe how to implement CDISC standards for the collection, representation, and exchange of tobacco product data with focus on implementation for common use cases in tobacco product submissions. Use cases are composed of concepts identified by CDISC TIG v1.0 team as important in the context of tobacco product studies. Use cases specifically addressed in the TIG are:

  • Product Description refers to concepts used to characterize tobacco products including product specifications, HPHCs, stability and ingredient listing.
  • Nonclinical 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 refers to concepts used to assess the impact of tobacco products on individuals.
  • Product Impact on Population Health refers to concepts used to assess the impact of tobacco products on populations of individuals.

Data standards for each use case are developed in separate workstreams composed of subject matter experts from FDA-CTP and industry.