新药物Ⅰ期临床试验病房规范化管理实践与效果  

The practice and effect of standardization management in the ward for phaseⅠnew drug clinical trial

作　　者：王泽娟[1] 王兴河[1] WANG Ze - juan WANG Xing - he(Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China)

机构地区：[1]首都医科大学附属北京世纪坛医院药物Ⅰ期临床试验研究室,北京市100038

出　　处：《护理管理杂志》2017年第6期430-432,共3页Journal of Nursing Administration

基　　金：首都医科大学附属北京世纪坛医院科研基金(2013-q05)

摘　　要：目的探讨新药物Ⅰ期临床试验病房规范化管理的有效方法。方法以药物临床试验质量管理规范为依据,结合临床护理工作,对新药物Ⅰ期临床试验病房的专科护理软硬件系统进行管理,从制订标准操作规程、专科研究护士准入培训和试验前中后的研究护士工作等方面进行专科护理管理。结果受试者及研究护士采集标本时间依从性均为100.00%;研究护士参加试验的角色满度提高(P<0.01)。结论规范化管理有利于Ⅰ期临床试验的实施完成,提高受试者和研究护士的依从性及临床试验质量。Objective To explore the standardization management method in phase I clinical trial ward. Methods On the basis of ＂Good Clinical Prac- tice ＂,combining with clinical nursing work, new drug phase I clinical trial software and hardware system were created, meanwhile the standardized management was implemented including developing standard operating procedures, qualifying and training the specialized research nurse, managing the nurse work before, dur- ing and after trials. Results The subjects＇adherence and the time adherence of samples collection for research nurses were both 100.00%. The role satisfaction of clinical research nurses increased （ P 〈 O. 01 ）. Conclusion Standardization management is conducive to the implementation of the phase I clinical trials, the compliance of subjects and research nurses and quality of clinical trials.

关 键 词：Ⅰ期临床试验病房 专科护理 护理管理 

分 类 号：C931.3[经济管理—管理学] R471[医药卫生—护理学]