COVID-19 Therapeutic Area User Guide v2.0

In April 2020, CDISC released an Interim User Guide in response to the COVID-19 Global Pandemic. To expedite its release, we did not follow the CDISC Standards Development Process. Subsequently, we developed version 1.0 of the COVID-19 Therapeutic Area User Guide (TAUG) by taking content from the Interim User Guide through our Standards Development Process to further refine and enhance the document.

Studies of any pandemic would benefit from many of the concepts in this TAUG, which could be leveraged for future science should the world face another infectious disease outbreak of this proportion.

We are now beginning development of COVID-19 TAUG v2.0, which will provide researchers with a comprehensive resource to implement CDISC standards in future pandemics. The TAUG will include CDASH and ADaM examples to aid researchers by simplifying the use of CDISC standards through end-to-end support for researchers for pandemics.

Funded in partnership with the IMI DRAGON project, the TAUG will also provide enhanced content for imaging, covering all concepts related to utilizing imaging for disease detection, diagnosis, and monitoring. This content will complement the focus of the DRAGON project’s artificial intelligence through imaging and clinical data.