Discussion of FDA Guidance Regarding COVID-19
#013 – One of the soft skills that I discussed last week, is the importance of being able to adapt to change. There is an example now causing so many changes, affecting all areas of the clinical research industry, COVID-19 (Coronavirus Disease 2019). The FDA recognizes that this pandemic is going to impact the conduct of clinical trials, and recently issued a guidance document for industry, investigators, and Institutional Review Boards regarding the conduct of clinical trials of medical products during the COVID-19 pandemic. Join me, as I review and discuss this guidance document and its recommendations for clinical trials.