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。

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.

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对研究者和申办者来说，不依从GCP要求的结果可能是严重的，但是本书我们最大的兴趣是受试者的结果。

The consequence of non-compliance with GCP requirements may be serious for the researcher and the sponsor, but in this book we are most interested in the consequences for the study subjects.

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