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.
一中央卫生或农业主管机关核发之药品输入、制造许可证影本或经核准之医药教育研究试验计画文件影本。
The copies of drug import and manufacture permit license issued by the Central Health or AgriculturalAdministration or of the approved medical and educational research projects.
在指定研究计划阶段，应产生下列文件并在试验正式开始之前归档。
During this planning stage the following documents should be generated and should be on file before the trial formally starts .
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