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.
Participation Requirements:
- Industry members must actively adopt TIG v1.0 standards within their organizations during the project.
- CTP and industry team members must complete the TIG online education curriculum at the project’s start.
Project Structure:
The project team, operating as a full team and through two workstreams, will meet monthly to review strategy, progress, and findings, with additional weekly workstream meetings (up to one hour, plus two hours of prep).
Workstreams:
- Education Workstream: Open to all adopters to strengthen CTP and industry knowledge and adoption of TIG v1.0 through focused educational content.
- Simulated eSubmission Workstream: Up to nine applicant organizations will apply TIG v1.0 standards in project-specific eSubmissions to CTP.
When submitting Volunteer Form, select "TIG V1.0 eSubmission Pilot" as the CDISC Standards Development team.
Contact Us
To join our mailing list and receive communications on the TIG eSubmission Pilot and/or indicate your interest to participate, use the form below to submit your contact information, questions, and/or feedback.
Tobacco industry experts are invited to participate as part of a multi-disciplinary team with membership from CTP, industry, and CDISC.
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.