Development of a CDISC Therapeutic Area Standard for Lung Cancer

首席调查员(最后、第一、中间)：基斯勒，布伦·维特 肿瘤学-肺癌数据标准的制定 项目摘要 该项目的目标是开发一个全球性的、非专有的数据标准 对于肺癌，利用CDISC标准制定过程和 CDISC共享元数据存储库。这个项目将导致 该治疗区域的规范，其中包括如何构建通常 在疾病临床试验中收集数据和结果测量。 该项目的具体目标是： 为肺癌临床研究开发数据标准，使用 CDISC标准制定流程。 确保与CDISC研究数据制表模型(SDTM)保持一致 FDA电子提交 NCI EVS中适用的规范肿瘤学概念和受控术语 术语系统 使用CDISC共享元数据资料档案库和其他工具支持 制定肺癌数据标准。 发布肺癌治疗区域标准并公开 可通过CDISC网站获取。 这个项目将通过几个不同的阶段共同完成 对标准制定过程进行了重大改进： 第0阶段-启动和范围确定：审查和批准项目建议书 并定义范围。 阶段1-确定疾病预防控制中心的概念：创建多个 纪律核心团队(包括FDA联系人)，审查可用的先前工作， 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。 阶段2-制定标准草案：核心团队制定详细的 以SDTM格式共享的元数据，用户指南草案。教育内容 是与标准开发专家共同开发的。 阶段3a-内部审查：相关CDISC对标准草案的审查 肺癌方面的团队和专家。 阶段3b-公众审查：公众对标准草案的审查 最少30天，批准为最终生产标准。 Stage 3c-公开发布：数据标准发布在CDISC网站上。 制定针对肺癌肿瘤学标准的教育内容 域名来教育用户。 在所有阶段，与Share团队合作以确定工具以 有效地制定治疗区域标准并提高可获得性 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.