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目的研究SARS临床多中心研究组织协调和质量控制及数据处理。方法在北京地区11家医院近1个月的中西医结合治疗SARS的多中心临床研究,结合现代数据处理技术对临床资料进行管理。结果通过组成多中心临床研究课题组及多学科交叉参与,联合攻关进行组织协调;采用统一顶层设计,制定临床研究者手册和数据采集、处理各环节标准操作规程,共同讨论临床设计方案,数据中心与临床一线联系沟通及时纠错来进行质量控制;通过建设数据库,建立数据处理原则和程序,及数据库与统计分析软件的连接对数据进行处理。结论将信息收集和处理作为临床研究设计和实施是现代临床研究的核心技术,并形成独特的方法和技术体系,提高临床研究质量、速度、效率和管理水平。
Objective To study the coordination, quality control and data processing of SARS multicenter clinical research. Methods A multicenter clinical trial was conducted to treat SARS in 11 hospitals in Beijing in the past month. Combining modern data processing techniques, clinical data were managed. Results Through the multi-center clinical research group and multidisciplinary cross-participation, joint research to organize and coordinate; using a unified top-level design, development of clinical researchers manual and data acquisition, processing standard operating procedures of various sectors to discuss clinical design programs, data centers And the clinical front-line communication and timely error correction to carry out quality control; through the construction of the database, the establishment of data processing principles and procedures, and database and statistical analysis software to connect the data processing. Conclusion The collection and processing of information as the clinical research design and implementation are the core technologies of modern clinical research. The unique methods and technical systems are formed to improve the quality, speed, efficiency and management of clinical research.