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药物临床试验GCP管理平台构建 被引量:4

Construction of Drugs Clinic Trials GCP Management Platform
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摘要 介绍临床试验GCP管理平台的研究与实现,阐明系统总体架构,从系统管理、试验管理、机构资源管理等方面分析系统功能,指出该系统的应用可以对药物临床试验实现全方位、规范化的信息管理。 The paper introduces the research and realization of clinic trials GCP management platform,elaborates the overall framework of the system,analyzes the function of the system from the aspects of system management,trial management,institutional resources management,etc.It points out that the system application could provide comprehensive and standardized information management for drug clinic trials.
作者 邱军 李刚荣
出处 《医学信息学杂志》 CAS 2012年第12期18-20,64,共4页 Journal of Medical Informatics
关键词 临床试验GCP管理平台 流程管理 架构 药物 Clinic trials GCP management platform Process management Framework Drugs
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  • 1马鑫良.药企应慎重选择物流运输[N].医药经济报,2005-06-06.
  • 2Cynthia A. Brandt, MD, MPH, Prakash Nadkarni, MD,et al. Controlled Clinical Trails, 2000, 21:440-461.
  • 3Rosanne M. Pogash, MPA, Susan J. Boehmer, MA et al.Control!ed Clinical Trails,2001,22:168-180.
  • 4William Nigel Strang,Michel Cucheral,et al.Methods and Programs in Biomedicine,2000,61:49-60.
  • 5Prakash Nadkarni MD.http://ycmi.med.yale.edu/nadkarni.
  • 6Guidance for Industry:Computerized System used in Clinical Trials http://www.fda.org.
  • 7Guidance for Industry:Providing Regulatory Submissions in Electronic Format-General Considerations http://ww.fda.org.
  • 821CFR Part 11:Electronic records,electronic signatures http://www.accassdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm.
  • 9ICH,Electronic Standards for the Transfer of Regulatory Information(ESTRI) http://www.ich.org.ich5m2.html.
  • 10Convergence Traction-Product Overview http://www.cmt-info.com/Product Overview.htm.

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