浅析伦理审查委员会档案材料的管理工作

Analysis on Archives Management of Ethics Committee

伦理审查委员会的档案材料分为六类:伦理审查委员会制度文档;伦理委员会委员资料;研究方案文档;会议记录;严重不良事件和意外不良事件报告伦理委员会的稽查和视察文件。通过分析伦理审查委员会档案材料管理工作存在的主要问题,提出伦理审查委员会档案管理的对策:提高管理人员对伦理审查委员会档案材料管理工作重要性的认识;档案材料管理工作应采用信息管理手段;健全伦理审查委员会档案材料管理制度,提高档案材料管理的规范性。

Archives of ethics committee are commonly divided into six categories ： system documents of commit- tee; materials of committee members; research plan documents; meeting minutes ; audit and inspection documents of serious adverse events and accident adverse events reported to committee. This paper analyses the problems ex isting in the archives management, and puts forward the countermeasures for the archives management： pay more attention to the importance of committee archives management ; computerized management methods should be adopt- ed in archives management; perfect the systems for archives management of ethics committee; improve the stand- ardization of archives management.