FDA Guidance on Conduct of ClinicalTrials of Medical Products During the COVID-19 Pandemic

Source: U.S. Food and Drug Administration (FDA). Published: 3/18/2020. The Food and Drug Administration (FDA) has issued this nine-page guidance to provide general considerations to assist sponsors in assuring the safety of trial participants in the conduct of clinical trials of medical products, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 (coronavirus) pandemic. It addresses the challenges that may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. (PDF)

https://disasterinfo.nlm.nih.gov/search/id:21312

Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - March 18, 2020 Category: International Medicine & Public Health Source Type: news