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Interim User Guide – COVID-19

Interim User Guide – COVID-19

CDISC have released an Interim User Guide, freely available on their website, for studies pertaining to COVID-19. The User Guide provides examples and guidance on implementing CDISC standards for COVID-19 so that users can collect, structure and analyze data more effectively.

The User Guide is part of a package that also includes:

  • Guidance for Ongoing Studies disrupted by the COVID-19 pandemic to represent changes in current studies if the conduct of ongoing studies is impacted by COVID-19.
  • An annotated case report form and a mapping spreadsheet to support public health researchers utilizing the Novel Coronavirus (nCoV) Acute Respiratory Infection Clinical Characterisation Data Tool.*

*Developed by the World Health Organization (WHO) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), the Data Tool is being used as the foundation for many COVID-19 research studies globally across numerous countries.

In late March, CDISC launched a task force with several member organizations and partners to rapidly develop the User Guide. Leveraging existing work from virology and infectious disease Therapeutic Area User Guides, CDISC expedited its standards development process to deliver the User Guide in less than a month.

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