In collaboration with the Center for Tobacco Products (CTP), CDISC has developed non-proprietary, consensus-based data standards for tobacco product regulatory submissions. Collectively referred to as the Tobacco Implementation Guide Version 1.0 (TIG v1.0), these standards and terminologies are specifically designed to support tobacco research, scientific review, harm reduction, and information exchange. Developed by a multi-disciplinary team of CTP, tobacco industry, and data standards experts, TIG v1.0 standards have the potential to expedite regulatory review and decision making as well as achieve efficiencies for all stakeholders. Support is needed post-publication to ensure successful adoption of standards by stakeholders within CTP and industry to achieve intended efficiencies. The TIG v1.0 Electronic Submission Pilot project is a continuation of the collaboration between CTP, Industry, and CDISC formed to develop the TIG v1.0. In this project TIG v1.0 standards will be implemented and submitted to FDA CTP by industry stakeholders.
Tobacco industry experts are invited to participate as part of a multi-disciplinary team with membership from CTP, industry, and CDISC.
Please indicate your interest by using the form below with questions and/or feedback regarding this initiative.