自动多实例REDCap数据同步NIH临床试验网络。

IF 3.4 Q2 HEALTH CARE SCIENCES & SERVICES
JAMIA Open Pub Date : 2025-05-24 eCollection Date: 2025-06-01 DOI:10.1093/jamiaopen/ooaf036
Meredith C B Adams, Cody Hudson, Wanchi Chen, Robert W Hurley, Umit Topaloglu
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引用次数: 0

摘要

目标:主要目标是开发一种自动化流程,用于连接临床试验网络中的研究电子数据捕获(REDCap)实例,以允许将研究调查转移到云计算数据公地以供发现。材料和方法:为了将远程临床试验站点的数据自动整合到协调/存储站点的一个数据集中,我们开发了一个超文本预处理脚本,该脚本与服务器端调度系统(如Cron)协同工作,为每个远程站点设置实用的数据提取计划。结果:REDCap应用程序编程接口(API)连接为跨分布式临床试验网络的多个REDCap实例之间的自动同步提供了一种新颖的实现,实现了研究站点和协调中心之间安全有效的数据传输。此外,协议检查器允许自动报告是否符合计划的数据库协议。讨论:从共享和接受的REDCap调查的核心库中工作是实现成功的关键。这种模式还有助于机构审查委员会(IRB)的批准,因为协调中心可以指定要转移的调查和数据元素。因此,受保护的健康信息可以根据IRB在协调中心级别给予的许可进行转换或保留。对于NIH HEAL临床试验网络,这种统一的数据收集工作的目标是创建一个去识别的数据集,以传输到第三代数据共享。结论:我们建立了几个简单且与研究相关的工具,REDCAP API Connection和REDCAP Protocol Check,以支持数据协调复杂性增加的临床试验网络的新需求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Automated multi-instance REDCap data synchronization for NIH clinical trial networks.

Automated multi-instance REDCap data synchronization for NIH clinical trial networks.

Automated multi-instance REDCap data synchronization for NIH clinical trial networks.

Automated multi-instance REDCap data synchronization for NIH clinical trial networks.

Objectives: The main goal is to develop an automated process for connecting Research Electronic Data Capture (REDCap) instances in a clinical trial network to allow for deidentified transfer of research surveys to cloud computing data commons for discovery.

Materials and methods: To automate the process of consolidating data from remote clinical trial sites into 1 dataset at the coordinating/storage site, we developed a Hypertext Preprocessor script that operates in tandem with a server-side scheduling system (eg, Cron) to set up practical data extraction schedules for each remote site.

Results: The REDCap Application Programming Interface (API) Connection provides a novel implementation for automated synchronization between multiple REDCap instances across a distributed clinical trial network, enabling secure and efficient data transfer between study sites and coordination centers. Additionally, the protocol checker allows for automated reporting on conforming to planned data library protocols.

Discussion: Working from a shared and accepted core library of REDCap surveys was critical to the success of this implementation. This model also facilitates Institutional Review Board (IRB) approvals because the coordinating center can designate which surveys and data elements to be transferred. Hence, protected health information can be transformed or withheld depending on the permission given by the IRB at the coordinating center level. For the NIH HEAL clinical trial networks, this unified data collection works toward the goal of creating a deidentified dataset for transfer to a Gen3 data commons.

Conclusion: We established several simple and research-relevant tools, REDCAP API Connection and REDCAP Protocol Check, to support the emerging needs of clinical trial networks with increased data harmonization complexity.

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来源期刊
JAMIA Open
JAMIA Open Medicine-Health Informatics
CiteScore
4.10
自引率
4.80%
发文量
102
审稿时长
16 weeks
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