Comments due: 
8 May 2020

Heart failure, sometimes called congestive heart failure, is a condition in which the heart cannot pump enough blood to meet the body's needs. Although there are different types of heart failure, they all result from conditions that weaken the heart. Heart failure can involve the heart’s left side, the right side, or both sides. This TAUG focuses primarily on chronic left-sided heart failure. Chronic heart failure is typically a long-term condition that gradually worsens over time. For an overview of the disease, please visit the American Heart Association.

Version 1.0 of the Therapeutic Area User Guide for Heart Failure (TAUG-Heart Failure v1.0)  is now entering the Public Review period to solicit your feedback. TAUG-Heart Failure v1.0 provides advice and examples for CDASHSDTM and ADaM including:

  • guidance on the use of domains and variables;

  • sample annotated case report forms (aCRFs);

  • examples of SDTM datasets, with text describing the situational context and pointing out records of note; and
  • guidance on the use of ADaM.  

View the draft: TAUG-Heart Failure v1.0

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Public review is a key quality step in our Standards Development Process. We rely on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research. Thank you for contributing your time and expertise.