A final close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files.
只有当监查员审核了研究者/研究机构及申办者双方的档案并确定所有必要的文件都在适宜的档案卷宗内,试验才能最后结束。
The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication.
监察者应该在访问每个试验临床地点或进行试验相关的交流之后向主办方递交一个书面报告。
A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
申办者组织的协调实施多中心试验的委员会。
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