另外,IND必须得到制度审核部门(the Institutional Review Board)的审核和批准。同时,后续的临床研究需至少每年向FDA提交一份进展报告并得到准许。
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The study was approved by our institutional review board and written informed consent was obtained from all subjects.
这项研究由我们的科研评价委员会通过,并获得了所有参与实验的患者的书面同意。
Such products are generally used under the supervision of an Institutional review Board, a committee that approves, monitors, and reviews biomedical research within a locality.
这种设备产品在RB机构的许可下是可以使用的,RB机构是当地一个批准,监督和重审生物医学研究委员会。
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