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.
临床部在中国为临床试验提供全面严谨的项目管理及监查服务,以保证临床试验的顺利进行。
The clinical Research Department provides comprehensive project management and monitoring services to ensure the smooth process of clinical trials performed in China.
临床监查:按照公司SOP、ICH-GCP的要求,对所负责临床试验项目进行及时有效的实施、执行和临床监查工作;
Monitoring: To perform clinical monitoring activities of clinical projects in a timely and effective manner according to SOPs and ICH GCP Guidelines.
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