Developing Acute Kidney Injury CDISC Clinical Data Standards for Clinical Research and Drug Development.

制定用于临床研究和药物开发的急性肾损伤 CDISC 临床数据标准。

• 批准号: 9899104
• 负责人: Sam HUME
• 金额: $ 9.99万
• 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/9899104
• 关键词: Developing; Acute; Kidney; Injury; CDISC

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 vasomotor symptoms due to menopause 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 vasomotor symptoms due to menopause standards. The new vasomotor symptoms due to menopause 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，以发展血管痉挛症状，由于更年期的标准， 收集（CDASH）、组织（SDTM）、分析（ADaM）、受控术语，以及 开发一些相关的量表、评级或量表（QRS），使用 建立CDISC流程和CDISC共享工具。CDISC将与CFAST 利益相关者以及CDISC全球社区参与这些新血管的开发 更年期标准的症状。更年期引起的新血管炎症状 标准将使数据更加清晰，并支持FDA审查许多不同的研究， 让他们“说同一种语言”。