摘要
目的探讨新药Ⅰ期临床研究中血标本采集的护理管理。方法对2009-2011年6个新药Ⅰ期临床试验项目的 8 956个血标本的采集进行全程管理。结果 8 956个血标本采集时间均控制在±1 min,无一个血标本出现溶血或凝血,血标本合格率在100%。结论加强护理人力资源、血标本采集的流程及消毒隔离工作与受试者的安全等各方面管理,能够保证血标本采集的质量及能为试验结果的分析或评价提供准确、客观的依据。
Objective To explore the nursing management of blood sample collection in phase Ⅰ clinical trial.Methods 8 956 cases of blood samples in six new drugs phase Ⅰ clinical trial program collected 2009-2011 were carried out overall management.Results The collecting time of 8 956 cases of blood samples were controlled within ±1 min,without a blood specimen hemolysis or clotting,the qualified rate of blood was 100%.Conclusion To strengthen the management of nursing human resources,blood specimen collection process,disinfection and isolation work and the safety of subjects,to ensure the quality of the blood samples,and provide evidence for analysis or evaluation of the test results.
出处
《中国医药导报》
CAS
2013年第1期163-164,共2页
China Medical Herald
关键词
Ⅰ期临床试验
血标本采集
护理管理
Phase Ⅰ clinical trial
Blood sample collection
Nursing management
