药物Ⅰ期临床试验病房的护理管理有效性分析  

Analysis on the effectiveness of nursing management in phase I clinical trial ward

作　　者：林绍静[1] 关灵[1] 杨欣仪 杜梓欣 LIN Shao-jing;GUAN Ling;YANG Xin-yi;DU Zi-xin(Phase I Clinical Trial Center,Dongguan People's Hospital,Dongguan Guangdong 523000,China)

机构地区：[1]东莞市人民医院I期临床试验中心,广东东莞523000

出　　处：《医学食疗与健康》2021年第28期246-247,共2页Medical Diet and Health

摘　　要：药物Ⅰ期临床试验病房是新药I期临床试验开展的场所,规范试验流程,通过有效管理降低风险显得尤为重要。文章通过总结分析药物Ⅰ期临床试验管理中的关键问题,从病房管理、受试者管理、药物管理、数据及文件管理等几个方面总结药物Ⅰ期试验护理管理的过程和方法,从而提高受试者依从性、护理满意度,降低护理不良事件发生率和失访率。The phase I clinical trial ward is the place where the phase I clinical trial of new drugs is carried out.It is particularly important to standardize the trial process and reduce the risk through effective management.By summarizing and analyzing the key problems in the management of phase I clinical trials,this paper summarizes the process and methods of nursing management of phase I clinical trials from the aspects of ward management,subject management,drug management,data and file management,so as to improve the subject compliance and nursing satisfaction,and reduce the incidence of nursing adverse events and loss of follow-up rate.

关 键 词：药物Ⅰ期临床试验病房 护理管理 有效性 

分 类 号：R197.323[医药卫生—卫生事业管理]