Howells Keith
Medidata Solutions Inc, 79 Fifth Avenue, 8th Floor, New York, NY 10003, USA.
IDrugs. 2008 Oct;11(10):733-7.
The implementation of a typical electronic data capture (EDC) system for clinical trials - encompassing data entry, validation and reporting tools - involves modeling electronic case report forms (eCRFs) for data that will be entered by investigative trial sites, providing web access for the sites to enter the data, managing a 'cleaning and locking' process (in which any queries against the data are resolved), and transmitting the final data to SAS datasets. Other clinical data not included in CRFs, such as laboratory data, are typically handled in a separate clinical data management system; this information is not directly linked back to the trial sites and therefore is inaccessible for review. Thus, activities such as seeking site feedback on out-of-range laboratory values can only be performed by manually transcribing queries from the data management system into the EDC system. As the number of studies using EDC systems escalates and the number of studies gathering data on paper diminishes, the inefficiencies of handling data across different systems are becoming increasingly apparent. This article explores the opportunities, risks and technical requirements needed for an integrated EDC environment to enable a discontinuation of the use of older data management systems.
用于临床试验的典型电子数据采集（EDC）系统的实施——包括数据录入、验证和报告工具——涉及为研究试验站点将要录入的数据对电子病例报告表（eCRF）进行建模，为各站点提供网络访问权限以录入数据，管理“清理和锁定”流程（在此过程中针对数据的任何疑问都将得到解决），并将最终数据传输到SAS数据集。病例报告表中未包含的其他临床数据，如实验室数据，通常在单独的临床数据管理系统中处理；此信息不会直接链接回试验站点，因此无法进行审查。因此，诸如就超出范围的实验室值寻求站点反馈等活动，只能通过将数据管理系统中的疑问手动转录到EDC系统中来执行。随着使用EDC系统的研究数量不断增加，而采用纸质收集数据的研究数量不断减少，跨不同系统处理数据的低效率问题日益明显。本文探讨了集成EDC环境所需的机遇、风险和技术要求，以便能够停止使用旧的数据管理系统。
