CDISC has released an Interim User Guide, freely available on the CDISC website, which the research community can utilize 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 analyze data more effectively.
CDISC is releasing the Interim User Guide as 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 utilizing 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.
“The CDISC global community of researchers, data scientists, and leaders from pharmaceutical companies, regulators, and key NGOs have rallied to our call for a rapid, robust response to COVID-19,” commented David R. Bobbitt, CDISC President and CEO. “Please let me express enormous gratitude and respect for our volunteers and staff who have produced in less than four weeks what we initially imagined might have required 18 months. It is our privilege on behalf of CDISC’s members to make these standards, examples, and all related content freely available immediately to all researchers in the world via CDISC.org.”
In late March, CDISC launched a task force with several member organizations 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.
Bobbitt continued, “I commend Chief Standards Officer Peter Van Reusel; Head of Standards Bess Leroy, MPH, and Head of Standards Amy Palmer for their leadership of the CDISC COVID-19 Task Force. As the science around COVID-19 continues to evolve, CDISC is prepared to do whatever it takes to ensure relevant clinical data standards and best practices are available to researchers around the globe.”
CDISC will hold a free, virtual webinar 6 May 2020 to review the Interim User Guide and best practices with implementers.
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org.