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CytoDyn Inc CYDY
(Total Views: 506)
Posted On: 12/14/2021 12:40:24 PM
Post# of 155779
Posted By: kabonk
Re: PTM1 #112451
I have some experience here as both someone who performs investigator initiated studies and so chose my own DSMC, and as an IRB member who has reviewed numerous protocols with DSMCs. Some requirements are that the DSMC should be mostly independent (but this is not always necessary), composed of experts in the subject matter, have a statistician, etc..., but no the FDA doesn't tell any researchers/sponsors who should be on the DSMC, only the "type" of person who is appropriate to serve the needed role (independent, expert, statistician for instance).













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