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Revising the ECRIN standard requirements for information technology and data management in clinical trials

机译:修订ECRIN对临床试验中信息技术和数据管理的标准要求

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The pilot phase of the ECRIN (European Clinical Research Infrastructure Network) certification programme for European data centres, in late 2011, led to a substantial revision of the original ECRIN standards, completed by June 2012. The pilot phase, the conclusions drawn from it and the revised set of standards are described. Issues concerning the further development of standards and related material are discussed, as are the methods available to best support that development. A strategy is outlined based on short-lived specific task groups, established as necessary by a steering group drawn from ECRIN-ERIC. A final section discusses possible future developments.
机译:2011年底,欧洲数据中心ECRIN(欧洲临床研究基础设施网络)认证计划的试验阶段导致对原始ECRIN标准进行了重大修订,并于2012年6月完成。试验阶段,由此得出的结论和描述了修订的标准集。讨论了与标准和相关材料的进一步开发有关的问题,以及可以最好地支持该开发的方法。根据短暂的特定任务组概述了策略,该任务组是根据需要从ECRIN-ERIC提取的指导小组建立的。最后一部分讨论了未来可能的发展。

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