Implementation of electronic data capture systems: Barriers and solutions
Implementation of electronic data capture systems: Barriers and solutions
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DOI：
10.1016/j.cct.2007.01.001
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发表时间：
2007-05-01
影响因子：
2.2
通讯作者：
Welker, James A.
中科院分区：
文献类型：
--
作者：
Welker, James A.
虽然正在加快步伐，但向电子数据采集（EDC）的转换一直进展缓慢。EDC系统的使用应提高数据完整性，节省成本，缩短研究数据库关闭时间。这将缩短新药上市时间和成本。目前业界的观点认为，成本分析已被接受为有利于EDC，传播使用的可能限制是无法实施这些系统。如果申办者、临床研究组织和研究中心的领导层认识到实施的障碍，他们可以在用户对新的数据采集方法不满和抵制之前预测并缓解这些障碍。一旦理解了这些障碍，诸如用户输入、技术支持、用户动机、监管要求、与用户的沟通、实施时间、软件安装、图形用户界面、桥接器的识别、患者参与、技术的可用性和成本等，就可以在实施过程的开始时得到更好的解决并成功地避免。本综述讨论了这些障碍和潜在的解决方案，可以帮助临床试验行业实现更广泛的EDC使用，并由此提高运营效率。(c)2007爱思唯尔公司All rights reserved.
Although increasing in pace, the conversion to Electronic Data Capture (EDC) has been a slow progression. The use of EDC systems should confer improved data integrity, cost savings and a shorter time to study database closure. This will reduce the time to market and cost of new medications. With the current sentiment of the industry suggesting the cost analysis has been accepted to be in favor of EDC, the likely limitation to disseminated use is an inability to implement these systems. If the leadership at the sponsor, clinical research organization and investigator site is cognizant of the barriers to implementation, they can anticipate and mitigate them prior to the users becoming disgruntled and resistant to the new method of data capture. Once understood, barriers such as user input, technical support, user motivation, regulatory requirements, communication with users, timing of implementation, software installation, graphical user interface, identification of bridgers, patient participation, availability of technology, and costs can be better addressed at the beginning of the implementation process and successfully averted. This review discusses these barriers and potential solutions that can assist the clinical trial industry in achieving more wide-spread EDC use and the resulting improvement in operating efficiencies. (c) 2007 Elsevier Inc. All rights reserved.