Jimenez-Maggiora Gustavo A, Bruschi Stefania, Qiu Hongmei, So Jia-Shing, Aisen Paul S
Alzheimer's Therapeutic Research Institute, Department of Neurology, Keck School of Medicine of USC, Los Angeles, California, USA.
JAMIA Open. 2022 Jan 17;5(1):ooab119. doi: 10.1093/jamiaopen/ooab119. eCollection 2022 Apr.
The Alzheimer's Therapeutic Research Institute (ATRI) developed a novel clinical data management system, the ATRI electronic data capture system (ATRI EDC), to address the complex regulatory, operational, and data requirements that arise in the conduct of multicenter Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRDs) clinical trials. We describe the system, its utility, and the broader implications for the field of clinical trials and clinical research informatics.
The ATRI EDC system was developed, tested, and validated using community-based agile software development methods and cloud-native single-page application design principles. It offers an increasing number of application modules, supports a high degree of study-specific configuration, and empowers study teams to effectively communicate and collaborate on the accurate and timely completion of study activities.
To date, the ATRI EDC system supports 10 clinical studies, collecting study data for 4596 participants. Three case descriptions further illustrate how the system's capabilities support diverse study-specific requirements.
The ATRI EDC system has several advantages: its modular capabilities can accommodate rapidly evolving research designs and technologies; its community-based agile development approach and community-friendly licensing model encourage collaboration per the principles of open science; finally, with continued development and community building efforts, the system has the potential to facilitate the effective conduct of clinical studies beyond the field of AD/ADRD.
By effectively addressing the requirements of multicenter AD/ADRD studies, the ATRI EDC system supports ATRI's scientific mission of rigorously testing new AD/ADRD therapies and facilitating the effective conduct of multicenter clinical studies.
阿尔茨海默病治疗研究所（ATRI）开发了一种新型临床数据管理系统，即ATRI电子数据采集系统（ATRI EDC），以满足在多中心阿尔茨海默病及与阿尔茨海默病相关的痴呆症（AD/ADRDs）临床试验开展过程中出现的复杂监管、操作和数据要求。我们描述了该系统、其效用以及对临床试验和临床研究信息学领域更广泛的影响。
ATRI EDC系统采用基于社区的敏捷软件开发方法和云原生单页应用设计原则进行开发、测试和验证。它提供了越来越多的应用模块，支持高度的研究特定配置，并使研究团队能够就准确及时完成研究活动进行有效沟通与协作。
截至目前，ATRI EDC系统支持10项临床研究，为4596名参与者收集研究数据。三个案例描述进一步说明了该系统的功能如何支持各种特定研究需求。
ATRI EDC系统具有多个优点：其模块化功能能够适应快速发展的研究设计和技术；其基于社区的敏捷开发方法和对社区友好的许可模式鼓励按照开放科学原则进行协作；最后，通过持续的开发和社区建设努力，该系统有潜力促进AD/ADRD领域之外临床研究的有效开展。
通过有效满足多中心AD/ADRD研究的要求，ATRI EDC系统支持了ATRI严格测试新的AD/ADRD疗法并促进多中心临床研究有效开展的科学使命。
