REDCap实现多中心研究数据管理的方法
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摘要
根据统计学的相关理论,好的临床研究需要较大的样本量支持,而单中心研究往往难以满足此要求,因此,多中心设计已成为当代临床研究的趋势。多中心研究中各中心在试验时产生大量数据,好的数据管理是多中心研究取得成功的关键环节之一。基于网络的电子数据采集系统REDCap为多中心研究数据管理提供了便利。本文主要介绍REDCap实现多中心研究数据管理的方法。
According to the relevant theory of statistics, good clinical research requires large sample sizes to support good power of test, and single-center research is often difficult to meet this requirement. Therefore, multicenter design has become the trend of contemporary clinical research. In the multi-center research, each center produces a large amount of data during the experiment. Good data management is one of the key links for successful multi-center research. REDCap, a web-based electronic data capture electronic, facilitates multi-center research data management. This article mainly introduces how to use REDCap to implement multi-center research data management.
According to the relevant theory of statistics, good clinical research requires large sample sizes to support good power of test, and single-center research is often difficult to meet this requirement. Therefore, multicenter design has become the trend of contemporary clinical research. In the multi-center research, each center produces a large amount of data during the experiment. Good data management is one of the key links for successful multi-center research. REDCap, a web-based electronic data capture electronic, facilitates multi-center research data management. This article mainly introduces how to use REDCap to implement multi-center research data management.
引文
[1]曾宪涛,李宾,吕军,等.全球临床研究的现状分析及趋势展望[J].中国循证心血管医学杂志,2017(12):1409-14.
[2]Polizzi C,Fontana V,Perricone G,et al.Coping Strategies and Locus of Control in Childhood Leukemia:A Multi-Center Research[J].Pediatr Rep,2015,7(2):5703.
[3]李娌,魏玉萍,钱芳桥,等.加强多中心临床研究的组织管理水平促进多中心临床研究质量提高[Z].中国江苏南京:20114.
[4]冷文玉,蒋志伟,于莉莉,等.电子数据捕获系统在新药临床试验中的影响[J].中国临床药理学与治疗学,2013(2):217-21.
[5]耿辉,贺海蓉,曾宪涛,等.多中心临床数据采集系统REDCap系统应用及架设[J].中国循证心血管医学杂志,2017(9):1025-8.
[6]Blumenberg C,Barros AJ.Electronic data collection in epidemiological research.The use of REDCap in the Pelotas birth cohorts[J].Appl Clin Inform,2016,7(3):672-81.
[7]Basak F,Hasbahceci M,Guner S,et al.Prediction of anxiety and depression in general surgery inpatients:A prospective cohort study of200 consecutive patients[J].Int J Surg,2015,23(Pt A):18-22.
[8]贺海蓉,郑婕,耿辉,等.如何利用REDCap数据采集系统实现病例报告表的设计[J].中国循证心血管医学杂志,2018,10(2):133-7.
[9]耿辉,贺海蓉,郑婕,等.多中心临床数据采集系统REDCap权限设置与管理[J].中国循证心血管医学杂志,2018,10(1):11-3.
[10]Gao HY,Li QN,Zhao Y,et al.[Effect of data management quality on clinical research evidence evaluation][J].Zhongguo Zhong Xi Yi Jie He Za Zhi,2015,35(2):239-42.
[2]Polizzi C,Fontana V,Perricone G,et al.Coping Strategies and Locus of Control in Childhood Leukemia:A Multi-Center Research[J].Pediatr Rep,2015,7(2):5703.
[3]李娌,魏玉萍,钱芳桥,等.加强多中心临床研究的组织管理水平促进多中心临床研究质量提高[Z].中国江苏南京:20114.
[4]冷文玉,蒋志伟,于莉莉,等.电子数据捕获系统在新药临床试验中的影响[J].中国临床药理学与治疗学,2013(2):217-21.
[5]耿辉,贺海蓉,曾宪涛,等.多中心临床数据采集系统REDCap系统应用及架设[J].中国循证心血管医学杂志,2017(9):1025-8.
[6]Blumenberg C,Barros AJ.Electronic data collection in epidemiological research.The use of REDCap in the Pelotas birth cohorts[J].Appl Clin Inform,2016,7(3):672-81.
[7]Basak F,Hasbahceci M,Guner S,et al.Prediction of anxiety and depression in general surgery inpatients:A prospective cohort study of200 consecutive patients[J].Int J Surg,2015,23(Pt A):18-22.
[8]贺海蓉,郑婕,耿辉,等.如何利用REDCap数据采集系统实现病例报告表的设计[J].中国循证心血管医学杂志,2018,10(2):133-7.
[9]耿辉,贺海蓉,郑婕,等.多中心临床数据采集系统REDCap权限设置与管理[J].中国循证心血管医学杂志,2018,10(1):11-3.
[10]Gao HY,Li QN,Zhao Y,et al.[Effect of data management quality on clinical research evidence evaluation][J].Zhongguo Zhong Xi Yi Jie He Za Zhi,2015,35(2):239-42.