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.

项目摘要-CDISC烟草标准项目 CDISC处于有利地位，可以协助FDA-CTP实现所有四大战略计划 RFA-FD-22-022中列出的目标和计划目标。CDISC，20多年来一直支持 开放、基于共识的标准开发，维护和促进了良好的 CDISC COP-001标准规定的已定义数据标准治理功能 发展[7]。CDISC的所有标准开发都遵循这一严格流程 确保质量和适用性，并鼓励广泛采用这些标准。 利用先前的丰富经验和上述标准制定过程， CDISC标准开发团队将让利益相关者参与 出版《烟草实施指南v1.0》、《合规规则》和 发展和 机器可读 烟草临床研究核心概念的生物医学概念(BCS)。合规性 规则，提供关键质量检查，以确保研究数据符合CDISC标准和BCS 可以在实现端到端自动化和可追溯性方面迈出重要一步。CDISC将确保 与FDA的CDISC研究数据制表模型(SDTM)的一致性和协调性 电子提交、临床数据标准协调(CDASH)和ADAM。这些 标准将在CDISC网站上免费提供。 CDISC数据科学团队将更新CDISC库模型和软件以加载和 生成BCS、新标准内容、准备实施的元数据和可执行文件的输出 在ODM和Define-XML中表示一致性规则和表示元数据 开发一个模型，将TAUG/基础内容包括在CDISC库[35]中，其中包括 能够生成现成的元数据和标准化标准的元数据内容。 CDISC还将开发教育内容，并提供给实施者和使用 多渠道传播/推广烟草的发布 实施指南v1.0和新的库功能，以进行更广泛的研究 社区。CDISC还建议利用FHIR-CDASH映射来支持CTP 探索真实世界数据(EHR)的应用。CDISC的现有标准目录，以及 凭借本申请中概述的创新方法和技术，将有助于定位 FDA-CTP将朝着优化活动的方向发展，以推进烟草研究、监管 烟草产品的提交、审查和决策以及上市后监督。

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.