id author title date pages extension mime words sentences flesch summary cache txt cord-325391-tgli4k5i Perez, Tamra Conducting clinical research in the era of Covid-19 2020-06-10 .txt text/plain 1357 85 54 Even now, investigators, industry sponsors, and institutional review boards/ethical committees (IRB/EC) struggle to maintain the safety of trial participants and researchers, while promoting the continuity of ongoing clinical studies. 6 The FDA, investigators, industry sponsors, and IRBs/ECs, among others, were required to act quickly to assess the status of ongoing studies and restructure research processes accordingly. 2 Industry sponsors are just now becoming aware that in order for research sites to begin to reopen their sites, COVID-19 testing may become a requirement for subjects as they are seen inperson for clinical visits as well as protocol-specified procedures. • Industry sponsors should be in contact with each investigative site to provide guidance on safety procedures to be continued such as labs or other vital status measurements. • In accordance with research informed consent requirements, investigators should maintain contact with trial subjects and keep them informed of protocol changes that could affect their participation (new information). ./cache/cord-325391-tgli4k5i.txt ./txt/cord-325391-tgli4k5i.txt