摘要
药物Ⅰ期临床试验是新药研发中临床阶段的第一步,其数据的准确性、可靠性、可溯源性至关重要。本院引进Abs Studio-Ⅰ软件,结合本院临床试验的需求与经验,对软件的模块功能进行优化与实践,初步建立了本院药物Ⅰ期临床试验全流程信息管理系统,可实现实时记录试验过程、结构化完整转译方案、自动扫描核对样本、嵌合医院信息系统(HIS)、在线开单、数据有痕修改与管理、多用户远程登录监管等功能。该系统的应用能提升药物Ⅰ期临床试验的实施质量,增强受试者的依从性,提高研究者工作效率,同时加大研究机构对临床试验过程的监管力度。
As phase Ⅰ clinical trial is the first step of clinical study of new drugs, the accuracy, reliability and traceability of its data is of great significance. A software named AbsStudio- Ⅰ was introduced, amended and optimized according to the practical experience and requirements of phase Ⅰ clinical trials in our hospital. Within the improved modules of AbsStudio- Ⅰ, an informationalized management system for phase Ⅰ clinical trials has been established, to realize functions including realtime recording of whole implementing process, structurized protocol interpretation, auto-scanning verification, incorporated HIS, online prescription, traceable data revision and management and multi-account login and monitoring, etc. Generally, application of informationalized management system was helpful to improve the implement attributed to advantages of better subject compliance, higher investigators strength and so on. quality of phase Ⅰ clinical trials, efficiency, stronger supervision
作者
易玲
张华
钱丽芳
黄晨蓉
尤晓明
缪丽燕
YI Ling ZHANG Hua QIAN Li-fang HUANG Chen-rong YOU Xiao-ming MIAO Li-yan(Drug Clinical Trials Institution/Laboratory of Phase Ⅰ Clinical Trials, the First Affiliated Hospital of Soochow University, Suzhou JIANGSU 215006, China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2017年第3期134-140,共7页
Chinese Journal of New Drugs and Clinical Remedies
关键词
临床试验
Ⅰ期
信息系统
临床方案
条形码系统
在线开单
prescriptionclinical trial, phase Ⅰ
information system
clinical protocols
barcode system
online
