Development of CDISC Therapeutic Area Standard for Colorectal Cancer

项目负责人/主要研究者（最后，第一，中间）：Kisler，Bron Witt CDISC结直肠癌治疗区标准的制定 项目摘要 本项目的目标是开发一个全球性的、非专有的CDISC数据标准， 癌症，利用CDISC标准开发过程。结直肠癌是第二大病因， 在美国，癌症相关的死亡率很高，这为研究和治疗带来了巨大的成本。的 CDISC结直肠癌治疗领域标准将用于监管申报和数据 收集新的临床试验。 该项目的具体目标包括： 通过与FDA和NCI以及更广泛的癌症研究的现有合作伙伴关系开展工作 社区使用CDISC制定CDISC结直肠癌治疗领域标准 标准制定过程。 确保与CDISC SDTM标准保持一致，以便向FDA进行电子监管申报。 通过我们与美国国家癌症研究所（NCI）的长期合作伙伴关系， 服务（EVS），提供适用的肿瘤学研究概念和受控术语， NCI EVS术语系统。 使用CDISC SHARE元数据库和其他工具来支持结肠直肠的开发 癌症数据标准。 发布CDISC结直肠癌治疗领域标准，通过以下方式公开发布 CDISC网站 该项目将通过几个不同的阶段完成，作为CDISC治疗领域的一部分 标准制定过程： 第0阶段-启动和范围界定：审查和批准项目提案并界定范围。 第一阶段-研究概念的确定：创建多学科核心团队（包括FDA） 联系人），审查现有的前期工作，设计概念图，创建新的概念图模板， 并与现有CDISC结构进行差距分析。 第二阶段-制定标准草案：核心团队为SDTM中的SHARE开发详细的元数据 格式、用户指南草稿。 第3.1阶段-内部审查：由CDISC相关团队和专家审查标准草案， 结肠直肠癌。 第3.2阶段-公众评审：由公众对标准草案进行至少30天的评审， 作为最终的生产标准。 第3.3阶段-公开发布：数据标准发布到CDISC网站。 使用CDISC SHARE元数据存储库和其他电子工具，最大限度地重用现有的 元数据和受控术语。

Program Director/Principal Investigator (Last, First, Middle): Kisler, Bron Witt Development of CDISC Therapeutic Area Standard for Colorectal Cancer Project Summary The objective of this project is to develop a global, non-proprietary CDISC data standard for Colorectal Cancer, utilizing the CDISC standards development process. Colorectal Cancer is the 2nd leading cause of cancer related deaths in the United States, which carries significant costs for research and treatment. The CDISC Therapeutic Area Standard for Colorectal Cancer will be used in regulatory submissions as well as data collection for new clinical trials. The Specific Aims of this project include:  Work through existing partnerships with FDA and NCI as well as the broader cancer research community to develop a CDISC Therapeutic Area Standard for Colorectal Cancer using the CDISC standards development process.  Ensure alignment with the CDISC SDTM standard for electronic regulatory submissions to the FDA.  Through our long-standing partnership with National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS), provide applicable oncology research concepts and controlled terminology coded in the NCI EVS terminology system.  Use the CDISC SHARE Metadata Repository and other tools to support development of the Colorectal Cancer data standard.  Publish a CDISC Therapeutic Area Standard for Colorectal Cancer, making it publicly available through the CDISC website. This project will be accomplished through several distinct stages as part of the CDISC therapeutic area standards development process:  Stage 0 – Initiation and Scoping: Review and approval of project proposal and define scope.  Stage 1 – Identification of Research 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.  Stage 3.1 – Internal Review: Review of draft standards by relevant CDISC teams and experts in Colorectal Cancer.  Stage 3.2 – Public Review: Review of draft standards by general public for a minimum of 30 days, approve as a final production standard.  Stage 3.3 – Public Release: Data standard posted to CDISC website.  Use CDISC SHARE Metadata Repository and other electronic tools to maximize the reuse of existing metadata and controlled terminology.