Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB HRPP policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...
Correspondence to Dr Thomas Bandholm, Dept of Clinical Research, Copenhagen University Hospital, Amager and Hvidovre, Hvidovre DK-2650, Denmark; thomas.quaade.bandholm{at}regionh.dk The REPORT guide ...
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