OBJECTIVE: To discuss the practice of our hospital in establishing and managing the drug clinical trial institution.
目的:为各医院药物临床试验机构的建设和管理提供参考。
Receiving training programs arranged by clinical trial institution for each project is a prerequisite to qualify investigators.
临床试验机构对研究者的培训,是研究者获得参加其所承担试验项目资格的必备条件。
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。
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