SAFETY MONITORING BOARD
\sˈe͡ɪfti mˈɒnɪtəɹɪŋ bˈɔːd], \sˈeɪfti mˈɒnɪtəɹɪŋ bˈɔːd], \s_ˈeɪ_f_t_i m_ˈɒ_n_ɪ_t_ə_ɹ_ɪ_ŋ b_ˈɔː_d]\
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Committees established to review interim data and efficacy outcomes in CLINICAL TRIALS. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.
By DataStellar Co., Ltd
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