The Interim User Guide for COVID-19 describes the most common biomedical concepts relevant to COVID-19, and the necessary metadata to represent such data consistently with Terminology, CDASH, and SDTM. CDISC Standards specify how to structure the data; they do not specify what data should be collected or how to conduct clinical trials, assessments or endpoints.
Guidance for Ongoing Studies Disrupted by the COVID-19 Pandemic
The Guidance addresses how to represent changes in current studies if the conduct is impacted by COVID-19.
Resources for Public Health Researchers
The zip file comprises 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.
CDISC would like to express our profound gratitude to the task force participants for their involvement in the development of these resources.