id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-346842-ip4i3bdk	Jeon, JuYeun	The Impact of COVID-19 on the Conduct of Clinical Trials for Medical Products in Korea	2020-09-07		.txt	text/plain	4168	204	47	METHODS: The impact on subject's scheduled visits and major milestones of clinical trials in Korea were measured by conducting a survey among clinical project manager (CPMs) working at global clinical research organization. New approaches were necessary in clinical trials to eliminate the risk of infection by complying with the guideline and enable subjects to continue to participate in trials if no better alternative treatment options were available, for protecting the subjects' safety and well-being. The study evaluated the impact of the COVID-19 epidemic and the KCDC disease control guideline on the conduct of clinical research in Korea, on subjects, investigators, monitor, pharmaceutical companies, Institutional Review Boards (IRBs) and regulatory authorities (RAs), in order to suggest recommendations for conducting clinical trials during the pandemic. The survey was distributed to total 140 clinical project manager (CPMs) who were working at global clinical research organization and responsible for trials performed in Korea, according to method of simple random sampling from February 24, 2020 to March 7, 2020.	./cache/cord-346842-ip4i3bdk.txt	./txt/cord-346842-ip4i3bdk.txt