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.

利用 CDISC 创新方法和新兴技术加快开放、端到端烟草标准的制定，以促进监管提交、审查和决策。

• 批准号: 10524770
• 负责人: Sam HUME
• 金额: $ 23.14万
• 依托单位: CLINICAL DATA INTERCHANGE STAND/CONSORT
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10524770
• 关键词: Leveraging; CDISC; innovative; approaches; emerging

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.

项目概要- CDISC烟草标准项目 CDISC处于有利地位，可以协助FDA-CTP实现所有四个总体计划战略 RFA-FD-22-022中列出的目标和项目目标。20多年来，CDISC一直支持 开放的、基于共识的标准开发，并保持和促进了良好的 由CDISC COP-001标准规定的定义的数据标准治理功能 发展[7]。所有CDISC标准的开发都遵循这一严格的流程， 确保质量和适用性，并鼓励广泛采用这些标准。 利用以往的丰富经验和上述标准制定过程， CDISC标准开发团队将与利益相关者一起参与 出版烟草实施指南v1.0、合规规则和 发展和 机器可读 生物医学概念（BC）的核心烟草临床研究概念。一致性 规则，提供关键的质量检查，以确保研究数据符合CDISC标准和BC 可以向端到端自动化和可追溯性迈出重要一步。CDISC将确保 与FDA的CDISC研究数据列表模型（SDTM）保持一致和协调 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， 生成BC、新标准内容、准备实施的元数据和可执行文件的输出 一致性规则的表示，并以ODM和Define-XML表示元数据， 开发一个模型，将TAUG/基础内容纳入CDISC库[35]，其中包括 能够生成随时可实施的元数据和规范性标准元数据内容。 CDISC还将开发教育内容，并将其提供给实施者和使用者。 通过多种传播/外联渠道宣传烟草的释放， 实施指南v1.0和新的图书馆功能，以更广泛的研究 社区CDISC还建议利用FHIR-CDASH映射，使CTP能够 探索真实世界数据（EHR）的应用。CDISC现有标准的目录，沿着 本申请中概述的创新方法和技术将有助于定位 FDA-CTP将致力于优化促进烟草研究和监管的活动 烟草产品的提交、审查和决策以及上市后监督。