摘要
文章以泰州市人民医院药物临床试验文件资料管理为背景,探讨药物临床试验文件资料管理的重要性和关键点。提出医院应重视药物临床试验文件资料的管理,建立完善的档案管理制度,从根本上保障药物临床试验资料的管理。
This article bases on document and record management of drug clinical trial in the People's hospital of Taizhou and focuses on importance and key points of document and record management of drug clinical trial.My findings indicate that realizing the importance of examination files and establishing excellent document and record management system are fundamental to managing document and record.
作者
董铖
DONG Cheng(Taizhou People's Hospital,Taizhou Jiangsu 225300,China)
出处
《泰州职业技术学院学报》
2018年第6期58-59,共2页
Journal of Taizhou Polytechnic College
关键词
药物临床试验
资料档案管理
新药批准
drug clinical trial
document and record management
new drug approval