June 14, 2024

On June 10, in partnership with the Clinical Data Interchange Standards Consortium (CDISC), FDA’s Center for Tobacco Products (CTP) released the Tobacco Implementation Guide – a new resource for stakeholders to use to help facilitate tobacco product research and scientific review. The resource–which includes data standards that can help optimize scientific accuracy and review efficiency–was created by a multidisciplinary team from CTP, tobacco industry stakeholders, and CDISC, and included public/community review.

CTP awarded a grant to CDISC to expedite the development of data standards and terminologies to facilitate tobacco research, scientific review, and information exchange. Specifically, CDISC created the Tobacco Implementation Guide to serve as a comprehensive resource for the collection, analysis, and exchange of tobacco product data for submissions to CTP, including tobacco product applications and research findings. Examples of tobacco product application submissions include Premarket Tobacco Product Applications (PMTAs), Substantial Equivalence (SE) reports, and Modified Risk Tobacco Product (MRTP) applications, and examples of research include epidemiology studies, toxicology reports, and behavioral studies. 

This initial version of the Guide implements several data models, including Clinical Data Acquisition Standards Harmonization, Study Data Tabulation Model, and Analysis Data Model. 
Comments and feedback to this guide can help inform future updates to the Tobacco Implementation Guide. CDISC posts public review comments and resolutions to ensure transparency and show implementers how comments were addressed.

View the Tobacco Implementation Guide