Independent IRB is an institutional review board structured in compliance
with the regulations of the Food and Drug Administration contained in the Code of
Federal Regulations (21 CFR 50 and 56), the Department of Health and Human Services
(45 CFR 46), and the Environmental Protection Agency (40 CFR 26). In addition, Independent
IRB is in compliance with the International Conference of Harmonization (ICH) and
Good Clinical Practice (GCP) guidelines for IRB/IECs as applicable.
The IRB is duly constituted, has written procedures for initial and continuing review
(full and expedited) of clinical trials, prepares written minutes of convened meetings
and retains records pertaining to the review and approval process as required by
regulatory agencies and applicable laws. Independent IRB is registered with
FDA/OHRP. IORG0002954 represents the overall registration, and IRB00003563 is the
IRB registration number.
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