Marks Ronald G
Department of Biostatistics, College of Medicine, University of Florida, P.O. Box 100212, Gainesville, FL 32610-0212, USA.
Control Clin Trials. 2004 Oct;25(5):437-46. doi: 10.1016/j.cct.2004.07.001.
The clinical trials industry relies heavily on paper-based source documents as the foundation for the collection of its clinical research data from human subjects and medical records. This focus on paper documents has been prevalent throughout the history of clinical trials conduct, even as computing solutions advanced throughout the past 20 years. With the advent of additional electronic capabilities recently with the growth of Internet-based products to enhance business operations in many fields, the clinical trials industry remains uniquely behind most other industries in electronic technology adoptions. Valid reasons exist for the slow growth of technology adoptions in clinical trial activities, but there are now discussions about how to use technology more effectively in clinical trial conduct. One area of enhanced clinical trial conduct is believed to be available by moving from paper-based source documents to electronic source documents, that is, eliminating paper from clinical data capture, and collecting the information initially in a computer system. An important concern in moving to electronic source data is the validation of such data. This paper summarizes the history of clinical data capture through paper and electronic advancements to date and identifies three reasons for the slow movement to more electronic source data. The paper then illustrates two methods for the validation of electronic source data.
临床试验行业严重依赖纸质源文件，将其作为从人体受试者和医疗记录中收集临床研究数据的基础。即使在过去20年计算机解决方案不断发展的情况下，专注于纸质文件在整个临床试验开展历史中一直很普遍。随着基于互联网的产品在许多领域促进业务运营的额外电子功能的出现，临床试验行业在采用电子技术方面仍然明显落后于大多数其他行业。在临床试验活动中技术采用增长缓慢存在合理原因，但现在也有关于如何在临床试验开展中更有效地使用技术的讨论。人们认为，通过从纸质源文件转向电子源文件，即从临床数据采集中消除纸张，并最初在计算机系统中收集信息，可以加强临床试验开展的一个领域。转向电子源数据时的一个重要问题是此类数据的验证。本文总结了迄今为止通过纸质和电子进步进行临床数据采集的历史，并确定了向更多电子源数据缓慢转变的三个原因。然后本文说明了两种验证电子源数据的方法。
