Development of a CDISC Therapeutic Area Standard for Lung Cancer

主要研究者（最后一名、第一名、中间名）：Kisler、Bron Witt 肿瘤学-肺癌数据标准的发展 项目摘要 该项目的目标是制定一个全球性的非专有数据标准 对于肺癌，利用CDISC标准开发过程和 CDISC SHARE元数据存储库。该项目将导致发展 该治疗领域的规范，其中包含如何构建 疾病临床试验中收集的数据和结果测量。 该项目的具体目标是： 使用《肺癌临床研究指南》制定肺癌临床研究数据标准 CDISC标准制定过程。 确保与CDISC研究数据列表模型（SDTM）保持一致， FDA电子提交 在NCI EVS中对适用的肿瘤学概念和受控术语进行编码 术语体系 使用CDISC SHARE元数据存储库和其他工具来支持 制定肺癌数据标准。 发布肺癌治疗领域标准并公开 可通过CDISC网站获得。 这个项目将通过几个不同的阶段结合起来完成 对标准制定过程进行了重大改进： 第0阶段-启动和范围界定：审查和批准项目提案 定义范围。 CDISC阶段1 -CDISC概念的识别和改进：创建多个 学科核心团队（包括FDA联系人），审查现有的先前工作， 设计概念图，创建新的概念图模板，并执行 与现有CDISC结构的差距分析。 第二阶段-制定标准草案：核心团队制定详细的 SDTM格式的SHARE元数据，用户指南草案。教育内容 与标准开发专家共同开发。 第3a阶段-内部审查：由相关CDISC审查标准草案 肺癌的治疗方法 第3b阶段-公众评审：由公众对标准草案进行评审， 至少30天，作为最终生产标准批准。 第3c阶段-公开发布：发布到CDISC网站的数据标准。 制定肺癌标准肿瘤学的教育内容 教育用户的领域。 在所有阶段，与SHARE团队合作确定工具， 有效制定治疗领域标准并提高可用性 电子格式的元数据。

Principal Investigator (Last, First, Middle): Kisler, Bron Witt Development of Oncology – Lung Cancer Data Standard Project Summary The objective of this project is to develop a global, non-proprietary data standard for Lung Cancer, utilizing the CDISC standards development process and the CDISC SHARE Metadata Repository. This project will lead to the development of specifications for that Therapeutic Area, which capture how to structure commonly collected data and outcome measurements in disease clinical trials. The Specific Aims of this project are:  Develop data standards for Lung Cancer clinical research studies using the CDISC standards development process.  Ensure alignment with the CDISC Study Data Tabulation Model (SDTM) for FDA electronic submissions  Code applicable oncology Concepts and controlled terminology in the NCI EVS terminology system  Use the CDISC SHARE Metadata Repository and other tools to support development of the Lung Cancer data standard.  Publish a Therapeutic Area Standard for Lung Cancer and make it publicly available via the CDISC Website. This project will be accomplished through several distinct stages in conjunction with major enhancements to the standards development process:  Stage 0 – Initiation and Scoping: Review and approval of project proposal and define scope.  Stage 1 – Identification a n d m o d e l i n g of CDISC Concepts: Create multi- disciplinary core team (including FDA contact), review available prior work, design concept maps, create new concept map templates, and perform gap analysis with existing CDISC constructs.  Stage 2 – Development of Draft Standards: Core team develops detailed metadata for SHARE in SDTM format, draft user guide. Education Content is developed in conjunction with Standards Development experts.  Stage 3a – Internal Review: Review of draft standards by relevant CDISC teams and experts in Lung Cancer.  Stage 3b – Public Review: Review of draft standards by general public for a minimum of 30 days, approve as a final production standard.  Stage 3c – Public Release: Data standard posted to CDISC website.  Develop Educational content specific for the Lung Cancer Standard oncology domains to educate users.  Throughout all stages, work with the SHARE team to determine tools to efficiently develop therapeutic area standards and improve availability of metadata in electronic format.