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IRB Statement of Assurance The Hackensack University Medical Center IRBs are duly constituted (fulfilling FDA requirements for diversity), has written procedures for initial and continuing review of clinical trials: prepares written minutes of convened meetings, and retains records pertaining to the review and approval purpose: all in compliance with requirements defined in 21 CFR 50, 56, and 213 (Code of Federal Regulations) and ICH (Internal Conference on Harmonization) guidance related to Good Clinical Practice. The Hackensack University Medical Center IRBs members are not permitted to remain in the meeting during discussion or vote on any protocol that may be an actual or perceived conflict of interest. Assurance identifier: FWA# FWA00000331 |
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