摘要
目的探讨如何更加精准和规范管理Ⅰ期临床试验。方法利用项目启动会、受试者招募筛选、病房护理以及用药管理等细则,排除临床试验中容易出现的问题,严格把控Ⅰ期临床试验数据和操作规范化进行。结果通过分析总结,制定一整套规范的Ⅰ期临床试验管理流程。结论Ⅰ期临床试验的规范化管理,能有效提高临床试验的研究质量,从而提升试验数据的真实性及可靠性。
OBJECTIVE The aim of this study is to promate the management of the phase I clinical trials more accurate and standard. METHODS Some methods, including program aetivations, recruitment of subjects, nursing ward, and medication management, were used to eliminate the errors in the course of the phase I clinical trials, and to guarantee the accuracy of the data and operate in clinical trials. RESULTS A series of the standard workflows were carried out via analysis and summary of experiment data in the phase I clinical trials. CONCLUSION The standardization management of the phase I clinical trials effectively improve the quality of clinical trials, and realize the authenticity and reliability of experiment data.
出处
《今日药学》
CAS
2017年第4期274-277,共4页
Pharmacy Today
关键词
临床实验研究中心
Ⅰ期临床试验
管理流程
clinical trials center
phase I clinical trial
operation management
