COVID-19 Therapeutic Area User Guide v2.0

Comments Due By


CDISC invites you to submit comments on version 2.0 of the COVID-19 Therapeutic Area User Guide (TAUG-COVID-19) during Public Review.

Funded in partnership with the IMI DRAGON project, the TAUG-COVID-19 v2.0 provides new content for imaging, covering concepts related to utilizing imaging for disease detection, diagnosis, and monitoring. It also enhances v1.0 by adding advice and examples for CDASH and ADaM. Please focus your review on the following new content:

  • Respiratory and Imaging Section
  • Analysis Module - ADaM examples
  • CDASH examples (in addition to those that are in Respiratory and Imaging)
    • Pre-existing Medical Conditions
    • Personal Protective Equipment (PPE)
    • Travel
    • Contacts
    • Smoking
    • Exposure to Animals
    • Signs and Symptoms - Example 1, Example 5
    • Laboratory Test Results
    • SARS-CoV-2 Viral Load

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 cdiscID.

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.