药物临床试验档案管理探讨  

Discussion about archive management for drug clinical trials

作　　者：齐松仁[1] 孙瑞华[1] 

机构地区：[1]中日友好医院科研处,北京100029

出　　处：《中华医学科研管理杂志》2009年第3期179-181,共3页Chinese Journal of Medical Science Research Management

摘　　要：阐述了药物临床试验档案的重要性，指出重视试验档案首先是重视临床研究者自己的辛勤劳动；其次药物试验档案是新药批准前接受项目核查的凭证；再次，药物试验档案是药物试验机构和专业认证时的重要依据。做好药物试验档案管理依靠制度保障。制度明确资料收集和整理人及其责任；明确收集内容；明确项目编码规则；明确交接规则；同时建立了制约机制。最后，指出了药物试验档案中目前常见的问题。This article elaborated on the importance of collecting archives of drug clinical trails. Taking the drug clinical trial archives into account, the first value is the effort of clinical researchers. Second, the archives of drug clinical trials are the requirement to obtaining the evaluation before the new drug projects are approved. Third, the archives are the important evidence as getting professional certification from relevant drug research organizations and governmental officials. Making good drug clinical archive management depends on the system and relevant regulations. A system should clarify the responsibilities of the collectors and managers for the archival materials. It also should make clear what are needs for collection, the rule of project numbering, and the rule of transferring. A good system also establishes the functionalities of monitoring and controlling. Last, the article pointed out the usual problem appeared in archive management of drug clinical trials.

关 键 词：药物 临床试验 档案管理 医院 

分 类 号：R95[医药卫生—药学]