Rare Diseases Therapeutic Area User Guide v1.0

Comments Due By


CDISC and our funding partner, the National Organization for Rare Disorders (NORD®),  invite you to submit comments on version 1.0 of the Rare Diseases Therapeutic Area User Guide (TAUG-Rare Diseases) during Public Review.

Although rare disease studies encompass a extensive set of therapeutic areas, the study of rare diseases shares many similarities and challenges for both collection and analysis. The TAUG-Rare Diseases v1.0 provides advice and examples for CDASH, SDTM, 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
  • Guidance on the use of ADaM.

TAUG-Rare Diseases is the first CDISC Therapeutic Area User Guide to include Gene Therapy examples.

To Provide Comments

You will need to log in or register for the CDISC Wiki to provide comments.

  • Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.

Public review is a key quality step in our Standards Development Process. 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.

Thank you for contributing your time and expertise.