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

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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’.