Can an investigator submit the study protocol instead of an outline of the study protocol? 1.23K viewsOctober 10, 2022FDA 0 Sam Smith11.38K October 7, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 7, 2020 0 Comments Spread the loveYes. The protocol or a detailed description is required for any phase 2 or 3 clinical trial. Phase 1 studies can be supported by an outline (see 21 CFR 312.53). Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login
