COVID 19流行感染病發生時關聯之品質保證與生命倫理

Quality Assurance and Bioethics in the Current COVID-19 Pandemic, A Necessary Linkage

As of March 11 2020 coronavirus disease (COVID-19) was declared as pandemic by the World Health Organization (WHO). As result, the impact of COVID-19 on ongoing and new clinical trials was, and still is, enormous: increasing demands on healthcare services, difficulties in distributing the investigational medicinal product, difficulties for investigators to schedule visits and conduct safety evaluations, as summary, difficulties in guarantee trial participant safety and data reliability in the global clinical research.