Developing Congestive Heart Failure CDISC Clinical Data Standards for Clinical Research and Drug Development.

项目摘要/摘要 CDISC在过去的20年里制定了基础标准，并发布了35项标准 过去五年与FDA合作的治疗区(TA)标准和更新- CDER，此外，目前有11个TA标准正在通过社区驱动的、 与CFAST组织和CDISC全球合作的基于协商一致的进程 评论者社区。该项目的目标是在现有CDISC临床的基础上 数据标准，以开发跨越收集的充血性心力衰竭标准(CDASH)， 组织(SDTM)、分析(ADAM)、受控术语以及制定许多 相关问卷、评级或量表(QR)，使用既定的CDISC流程和 CDISC共享工具。CDISC将与CFAST利益相关者以及CDISC全球 社区正在制定这些新的充血性心力衰竭标准。新的 充血性心力衰竭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”。

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 congestive heart failure 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 congestive heart failure standards. The new congestive heart failure standards will bring clarity to data and support FDA in reviewing many different studies and allowing them to ‘speak the same language’.