Clark Katie, Ruth Caleb, Thomas Kathryn A, Dunham Katherine, Travis Madelene, Rivera-Santiago Kristian, Brinkely-Rubinstein Lauren, Wang Emily
Department of Internal Medicine, SEICHE Center for Health and Justice, Yale School of Medicine, New Haven, CT, USA.
Research Allies LLC, Denver, CO, USA.
J Clin Transl Sci. 2023 Aug 14;7(1):e183. doi: 10.1017/cts.2023.609. eCollection 2023.
Choosing an appropriate electronic data capture system (EDC) is a critical decision for all randomized controlled trials (RCT). In this paper, we document our process for developing and implementing an EDC for a multisite RCT evaluating the efficacy and implementation of an enhanced primary care model for individuals with opioid use disorder who are returning to the community from incarceration.
Informed by the Knowledge-to-Action conceptual framework and user-centered design principles, we used Claris Filemaker software to design and implement CRICIT, a novel EDC that could meet the varied needs of the many stakeholders involved in our study.
CRICIT was deployed in May 2021 and has been continuously iterated and adapted since. CRICIT's features include extensive participant tracking capabilities, site-specific adaptability, integrated randomization protocols, and the ability to generate both site-specific and study-wide summary reports.
CRICIT is highly customizable, adaptable, and secure. Its implementation has enhanced the quality of the study's data, increased fidelity to a complicated research protocol, and reduced research staff's administrative burden. CRICIT and similar systems have the potential to streamline research activities and contribute to the efficient collection and utilization of clinical research data.
对于所有随机对照试验（RCT）而言，选择合适的电子数据采集系统（EDC）是一项关键决策。在本文中，我们记录了为一项多中心RCT开发和实施EDC的过程，该试验旨在评估一种针对从监禁中回归社区的阿片类药物使用障碍个体的强化初级保健模式的疗效和实施情况。
以知识转化为行动概念框架和以用户为中心的设计原则为指导，我们使用Claris Filemaker软件设计并实施了CRICIT，这是一种新型EDC，能够满足我们研究中众多利益相关者的不同需求。
CRICIT于2021年5月部署，此后一直在不断迭代和调整。CRICIT的功能包括广泛的参与者跟踪能力、特定地点的适应性、集成随机化方案以及生成特定地点和全研究范围总结报告的能力。
CRICIT具有高度可定制性、适应性和安全性。其实施提高了研究数据的质量，增强了对复杂研究方案的依从性，并减轻了研究人员的行政负担。CRICIT及类似系统有可能简化研究活动，并有助于临床研究数据的高效收集和利用。
