Data Performance LLC, Ithaca, NY, United States.
Division of Nutritional Sciences, Cornell University, Ithaca, NY, United States.
J Med Internet Res. 2020 Aug 13;22(8):e18580. doi: 10.2196/18580.
When we were unable to identify an electronic data capture (EDC) package that supported our requirements for clinical research in resource-limited regions, we set out to build our own reusable EDC framework. We needed to capture data when offline, synchronize data on demand, and enforce strict eligibility requirements and complex longitudinal protocols. Based on previous experience, the geographical areas in which we conduct our research often have unreliable, slow internet access that would make web-based EDC platforms impractical. We were unwilling to fall back on paper-based data capture as we wanted other benefits of EDC. Therefore, we decided to build our own reusable software platform. In this paper, we describe our customizable EDC framework and highlight how we have used it in our ongoing surveillance programs, clinic-based cross-sectional studies, and randomized controlled trials (RCTs) in various settings in India and Ecuador.
This paper describes the creation of a mobile framework to support complex clinical research protocols in a variety of settings including clinical, surveillance, and RCTs.
We developed ConnEDCt, a mobile EDC framework for iOS devices and personal computers, using Claris FileMaker software for electronic data capture and data storage.
ConnEDCt was tested in the field in our clinical, surveillance, and clinical trial research contexts in India and Ecuador and continuously refined for ease of use and optimization, including specific user roles; simultaneous synchronization across multiple locations; complex randomization schemes and informed consent processes; and collecting diverse types of data (laboratory, growth measurements, sociodemographic, health history, dietary recall and feeding practices, environmental exposures, and biological specimen collection).
ConnEDCt is customizable, with regulatory-compliant security, data synchronization, and other useful features for data collection in a variety of settings and study designs. Furthermore, ConnEDCt is user friendly and lowers the risks for errors in data entry because of real time error checking and protocol enforcement.
当我们无法找到一个支持我们在资源有限地区进行临床研究要求的电子数据采集 (EDC) 包时，我们着手构建自己的可重复使用的 EDC 框架。我们需要在离线时捕获数据，按需同步数据，并执行严格的资格要求和复杂的纵向协议。根据以往的经验，我们进行研究的地理区域通常互联网接入不可靠且缓慢，这使得基于网络的 EDC 平台变得不切实际。我们不愿意退回到基于纸质的数据采集，因为我们希望 EDC 具有其他优势。因此，我们决定构建自己的可重复使用的软件平台。在本文中，我们描述了我们的可定制 EDC 框架，并重点介绍了我们如何在印度和厄瓜多尔的各种环境中使用该框架进行正在进行的监测计划、基于诊所的横断面研究和随机对照试验 (RCT)。
本文描述了创建一个移动框架，以支持各种环境中的复杂临床研究方案，包括临床、监测和 RCT。
我们使用 Claris FileMaker 软件为 iOS 设备和个人计算机开发了 ConnEDCt 移动 EDC 框架，用于电子数据捕获和数据存储。
ConnEDCt 在印度和厄瓜多尔的临床、监测和临床试验研究环境中进行了现场测试，并不断进行优化，包括特定用户角色；在多个地点同时同步；复杂的随机化方案和知情同意过程；以及收集各种类型的数据（实验室、生长测量、社会人口学、健康史、膳食回忆和喂养实践、环境暴露和生物样本采集）。
ConnEDCt 具有可定制性、符合法规要求的安全性、数据同步和其他有用功能，可用于各种环境和研究设计的数据收集。此外，ConnEDCt 用户友好，降低了数据输入错误的风险，因为它具有实时错误检查和协议执行功能。
