Developing Psoriasis CDISC Clinical Data Standards for Clinical Research and Drug Development.

制定用于临床研究和药物开发的银屑病 CDISC 临床数据标准。

• 批准号: 9899108
• 负责人: Sam HUME
• 金额: $ 9.96万
• 依托单位: CLINICAL DATA INTERCHANGE STAND/CONSORT
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9899108
• 关键词: Developing; Psoriasis; CDISC; Clinical; Data

Project Summary/Abstract CDISC has developed foundational standards over the last twenty years and published thirty-five Therapeutic Area (TA) standards and updates for the past five years in collaboration with FDA- CDER, in addition eleven TA standards are currently in development through a community-driven, consensus-based process in collaboration with CFAST organizations and the CDISC global community of reviewers. The objectives of this project are to build on existing CDISC clinical data standards to develop psoriasis standards that span collection (CDASH), organization (SDTM), analysis (ADaM), controlled terminology, as well as develop a number of relevant Questionnaires, Ratings or Scales (QRS), using established CDISC processes and CDISC SHARE tools. CDISC will engage CFAST stakeholders as well as the CDISC global community in the development of these new psoriasis standards. The new psoriasis standards will bring clarity to data and support FDA in reviewing many different studies and allowing them to ‘speak the same language’.

项目总结/摘要 CDISC在过去的二十年中开发了基础标准，并发布了35个 与FDA合作制定的治疗领域（TA）标准和过去五年的更新- CDER，此外，11个TA标准目前正在通过社区驱动的， 与CFAST组织和CDISC全球合作， 评论家社区本项目的目标是在现有CDISC临床 数据标准，以制定牛皮癣标准，跨越收集（CDASH），组织 （SDTM），分析（ADaM），受控术语，以及制定一些相关的 使用已建立的CDISC流程和CDISC， 分享工具。CDISC将与CFAST利益相关者以及CDISC全球社区合作 在这些新的牛皮癣标准的发展。新的牛皮癣标准将带来 明确数据，支持FDA审查许多不同的研究，并允许他们“发言” 同样的语言”。