摘要
我院医学伦理委员会近5年通过临床试验项目管理系统(clinical trial management system,CTMS)伦理模块,审查药物临床试验和科研临床试验2 388项。CTMS以《药物临床试验质量管理规范(GCP)》和药物临床试验标准操作规程(SOP)为依据,从受理、申请、审查、会议安排覆盖整个临床试验的全过程。CTMS促进了临床研究的规范化实施,提高伦理审查的效率和质量,并为试验项目的管理和决策提供精准的数据支持。
A total of 2 388 drug clinical trials and investigator-initiated clinical trials have been approved by ethics committee for 5 years,via the Clinical Trial Management System( CTMS). Based on the Good Clinical Practice( GCP) and Standard Operation Procedure( SOP) in hospital,CTMS covered an entire workflow for clinical trials,including the acceptance,application,review and meeting arrangement. It was proved that the system could promote the standardize implementation of clinical trials,enhance the efficiency and quality of ethic review,improve the efficiency,and provide precise data support for management and decision of clinical trials.
作者
曹江
梁蓓蓓
白楠
许芳
蔡芸
王睿
王瑾
CAO Jiang;LIANG Bei-bei;BAI Nan;XU Fang;CAI Yun;WANG Rui;WANG Jin(Medicine Clinical Research Center of Chinese PLA General Hosptial, Beijing 100853, China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2018年第11期1283-1285,共3页
Chinese Journal of New Drugs
基金
解放军总医院科技创新苗圃基金项目(17KMM46):基于风险的临床试验质量量化管理模型和预警机制研究
关键词
医学伦理
临床试验
信息化
管理
ethics committee
clinical trials
informatization
management