An eSubmission pilot with stakeholder education to ensure successful adoption of data standards by regulators, industry, and global organizations for tobacco research, regulatory review, data sharing. - 7. Project Summary/Abstract This proposed project is a continuation of the collaboration between CDISC and CTP formed to develop the Tobacco Implementation Guide (TIG) v1. In response to RFA-FD-24-001, this project will build on prior work done with CTP and directly address overarching project goals and objectives leveraging innovative tools and technologies. These innovative tools and technologies include the development of Biomedical Concepts (BCs), CDISC Library, the Operational Data Model (ODM), Analysis Results Standard (ARS) and CDISC Open Rules Engine (CORE). CDISC is well positioned support the CTP in achieving the overarching goals of supporting open, consensus-based, data standards development, promoting eSubmission of regulatory data using established standards and facilitating CTPs review process to leverage data conformed to standards. Leveraging previous experience and a well-established governance and open consensus-based standards development process CDISC will engage stakeholders to achieve the following aims: Aim 1: Initiation of stakeholder adoption and further refinement of Tobacco Implementation Guide v1.0 CDISC standards for submissions to CTP through an electronic submission (e-Submission) pilot. Aim 2: Development of a documented framework for long-term collaboration, support, and refinements to Tobacco Implementation Guide v1.0 standards for subsequent e-Submissions and other data standardization needs. Aim 3: Provision and creation of educational content to promote support understanding of the value of data standards in research and to support consistent implementation of TIG v1.0 standards for submissions to CTP.
