PTSD Therapeutic Area User Guide Public Review


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Version 1.0 of the Post Traumatic Stress Disorder Therapeutic Area User Guide (TAUG-PTSD) describes the most common biomedical concepts relevant to studies to treat PTSD and the necessary metadata to represent such consistently with CDISC standards, such as CDASH, SDTM, and ADaM. TAUG-PTSD v1.0 was funded by Cohen Veterans Bioscience and developed through the Coalition for Accelerating Standards and Therapies (CFAST) initiative and the CDISC Standards Development Process.

TAUGs extend the Foundational Standards to represent data that pertains to specific disease areas and include disease-specific metadata, examples and guidance on implementing CDISC standards for a variety of uses, including global regulatory submissions.

CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.


Presenters
  • Allyson Gage
  • Amy Palmer
  • Dana Booth
  • Kathleen Mellars
Language: English