Leveraging CDISC innovative approaches and emerging technology to expedite development of open, end-to-end tobacco standards to facilitate regulatory submission, review and decision making.

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Project Summary – CDISC Tobacco Standards Project CDISC is well positioned to assist FDA-CTP in achieving all four overarching program strategic goals and program objectives listed in RFA-FD-22-022. CDISC, for over 20 years, has supported open, consensus based, standards development and has maintained and promoted a well- defined data standards governance function regulated by CDISC COP-001 Standards Development [7]. All CDISC standards development follow this rigorous process to ensure quality and fitness for use as well as encourage the wide adoption of the standards. Leveraging deep previous experience and the standards development process mentioned above, the CDISC Standards Development Team will engage stakeholders in the publication of a Tobacco Implementation Guide v1.0, conformance rules and development and machine-readable Biomedical Concepts (BCs) for core tobacco clinical research concepts. Conformance rules, provide a critical quality check in ensuring study data conform to CDISC standards and BCs can result in a significant step towards end-to-end automation and traceability. CDISC will ensure alignment and harmonization with the CDISC Study Data Tabulation Model (SDTM) for FDA electronic submissions, Clinical Data Standards Harmonization (CDASH), and ADaM. These standards will be freely available on the CDISC website. The CDISC Data Science team will update the CDISC Library model and software to load and generate outputs for BCs, new standards content, ready-to-implement metadata, and executable representations of conformance rules and represent metadata in ODM and Define-XML and develop a model to include TAUG/Foundational content into CDISC Library [35] that includes the ability to generate ready-to-implement metadata and normative standards metadata content. CDISC will also develop educational content and make it available to implementers and utilize multiple channels of dissemination/outreach to communicate the release of the Tobacco Implementation Guide v1.0 and the new Library features to the broader research community. CDISC also proposes to leverage the FHIR-CDASH mapping to enable CTP to explore application of Real-World Data (EHR). CDISC’s catalogue of existing standards, along with the innovative approaches and technology outlined in this application will help to position FDA-CTP to move toward optimizing activities that advance tobacco research, regulatory submission, review and decision making and post marketing surveillance of tobacco products.