id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-284502-nesvd10a	Singh, Arjun Gurmeet	Clinical trials during COVID‐19	2020-05-02		.txt	text/plain	1603	90	47	Sponsors need to take into account the national guidelines and restrictive measures imposed including limitations of trial participants and staff confinements and their ability to perform visits, interviews and forms, and notification of adverse effects. The risk-benefit section of protocols should include the additional risks that the participant and trial workers could encounter due to COVID-19 with adequate risk mitigation measures. Clinical investigators and sponsors should consult their Institutional Review Boards (IRBs) or Institutional Ethics Committees (IECs) in deciding if the participants' safety and rights are best served and protected by participating in the ongoing study or by discontinuing the IMP, intervention or even participation in the trial. Since trial participants may not be able to visit the site for the protocol specific visits and investigations, sponsors should evaluate if alternate measures such as virtual visits, alternate locations for assessment, including imaging centers and labs, could suffice when necessary, only after ensuring the safety of the participant.	./cache/cord-284502-nesvd10a.txt	./txt/cord-284502-nesvd10a.txt