摘要
药物临床试验档案指的是药物在临床试验过程活动中的全部记录,药物临床试验档案管理是药物上市申报的重要凭证材料,同样是保护药物受试者安全与权益的重要材料。但是,在药物临床试验档案的实际管理中,往往会受到很多因素的影响,导致药物临床档案管理中出现未按时归档、归档的资料缺乏完整性、丢失原始资料,缺乏真实性、资料管理不规范、硬件设施不完善、电子化管理水平低下等问题。为更好地保障药物临床试验档案管理效果,通过构建完整的药物临床试验档案资料管理制度、规范药物临床试验资料的收集与归档、提升管理人员素质、规范药物临床试验档案资料的整理工作、完善软件与硬件管理条件、实行药物临床试验档案电子化管理等措施来进行干预,以更好地提升药物临床试验档案管理效果,为药物临床事业的发展起到促进作用。
Drug clinical trial files refer to all records of drugs in the course of clinical trials.Drug clinical trial file management is an important credential material for drug listing application,and it is also an important material for protecting the safety and rights of drug subjects.However,in the actual management of drug clinical trial files,it is affected by many factors,as a result,in the management of drug clinical files,there are problems such as failure to file on time,lack of integrity of archived materials,loss of original materials,lack of authenticity,irregular data management,imperfect hardware facilities and low level of electronic management.In order to better ensure the effect of drug clinical trial file management,by constructing a complete management system for drug clinical trial archives,standardizing the collection and filing of drug clinical trial data,improving the quality of management personnel,standardizing the sorting of drug clinical trial archives,improving software and hardware management conditions,and implementing electronic management of drug clinical trial files,so as to better improve the effect of drug clinical trial file management,to play a role in promoting the development of drug clinical careers.
作者
李梅
陈璐
倪穗琴
LI Mei;CHEN Lu;NI Suiqin(Department of Clinical Pharmacy,Guangzhou First People's Hospital,Guangzhou,Guangdong Province,510180 China)
出处
《中国卫生产业》
2022年第9期78-81,共4页
China Health Industry
关键词
药物临床试验
档案管理
问题
对策
Drugs clinical trials
File management
Problems
Countermeasures
