COVID-19 Therapeutic Area User Guide v1.0

In March 2020, CDISC assembled a task force of participants from industry, the US Food and Drug Administration (FDA), the US National Institutes of Health (NIH), the World Health Organization (WHO), and academia to rapidly develop guidance on standardizing COVID-19 research data. Due to the public health significance of COVID-19, we expedited the CDISC Standards Development Process to develop and release an Interim User Guide for COVID-19 in three and half weeks.

Subsequently, version 1.0 of the Therapeutic Area User Guide for COVID-19 began development under the formal CDISC Standards Development Process and is now entering the Public Review period to solicit feedback.

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


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.