伦理审查委员会文件归档规范化的探讨  

Discussion on Standardized Management of Institutional Review Board Archives

作　　者：刘丹茹[1] 张雪[1] 尹梅[1] 崔晶微[2] 

机构地区：[1]哈尔滨医科大学人文社会科学学院,黑龙江哈尔滨150081 [2]哈尔滨医科大学附属第一医院,黑龙江哈尔滨150001

出　　处：《医学与哲学（A）》2013年第5期26-28,共3页Medicine & Philosophy:Humanistic & Social Medicine Edition

基　　金：黑龙江省自然科学基金项目"跟踪审查:药物临床试验伦理审查监督机制的影响因素与效果研究";项目编号:G201102;哈尔滨医科大学伍连德青年科学基金项目"伦理审查委员会跟踪审查制度作用机制的研究与实践";项目编号:WLD-QN1108

摘　　要：我国伦理审查委员会文件归档的规范化管理尚处于起步阶段。在对伦理审查委员会文件归档内涵界定的基础上,阐述了文件归档不规范的弊端和规范化管理的意义,探讨了文件归档的范围和规范化管理过程中存在的问题。最后从强化规范化归档意识、完善操作规程体系、采用现代化管理手段等方面提出完善建议。The standardized management of Chinese Institutional Review Board archives is still in the primary stage. Through defining the concept of Institutional Review Board archives, the paper illustrated the abuse of disorder archives and significance of standardized management, discussed the archives range and problems in standardized management process. The propound suggestions of strengthening the standardized consciousness, perfecting the standard operating pro- cedure system and employing modern means were provided.

关 键 词：伦理审查委员会 文件归档 规范化管理 

分 类 号：R-052[医药卫生]