CDISC Interim User Guide released

The Interim User Guide, freely available on the CDISC website, which the research community can utilise to represent data in studies pertaining to COVID-19. The Interim User Guide provides examples and guidance on implementing CDISC standards for COVID-19 so that researchers can collect, structure and analyse data more effectively.

It forms part of a package to drive critical breakthroughs in research for COVID-19. This package also includes a CDISC Guidance for Ongoing Studies Disrupted by the COVID-19 Pandemic as well as an annotated case report form and a mapping spreadsheet to support public health researchers utilising the Novel Coronavirus (nCoV) Acute Respiratory Infection Clinical Characterisation Data Tool. The Data Tool was developed by the World Health Organization (WHO) and the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) and is being used as the foundation for many COVID-19 research studies in numerous countries.

In late March, CDISC launched a task force with several member organisations and partners to rapidly develop the User Guide and related materials. Leveraging existing work from virology and infectious disease Therapeutic Area User Guides, CDISC expedited its standards development process to deliver the information to the research community.

IDDO Associate Director Laura Merson said: "The broad scope of the COVID-19 Interim User Guide will help accelerate cross-disciplinary science to address the complex needs of the pandemic. From clinical data, to vaccines, to epidemiological risk factors, the broad scope of this tool further establishes CDISC as the standards for human health."

CDISC will hold a free, virtual webinar 6 May 2020 to review the Interim User Guide and best practices with implementers.

Read the full press release here.