The practice and effect of standardization management in the ward for phase Ⅰ new drug clinical trial
WANG Ze-juan
WANG Xing-he
Abstract：Objective To explore the standardization management method in phase Ⅰ clinical trial ward.Methods On the basis of "Good Clinical Practice ",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,during 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 ＜ 0.01).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.
Keywords：the phase Ⅰ clinical trial wardspecific nursingnursing management
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 430-432 )