What level of detail is needed in this description? 1.34K viewsOctober 10, 2022FDA 0 Sam Smith11.38K October 30, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 30, 2020 0 Comments Spread the loveSubmitting documentation of the informed consent process detailed in ICH E6, section 4.8, and/or relevant sections of ICH E3 is one acceptable means of meeting the requirement in 21 CFR 312.120(b)(8) to describe how informed consent was obtained. Spread the love Login
