Scrybe: A Secure Audit Trail for Clinical Trial Data Fusion.

Digital threats : research and practice Pub Date : 2023-06-01 Epub Date: 2022-03-10 DOI:10.1145/3491258
Jonathan Oakley, Carl Worley, L U Yu, Richard R Brooks, Ilker Özçelik, Anthony Skjellum, Jihad S Obeid
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Abstract

Clinical trials are a multi-billion dollar industry. One of the biggest challenges facing the clinical trial research community is satisfying Part 11 of Title 21 of the Code of Federal Regulations [7] and ISO 27789 [40]. These controls provide audit requirements that guarantee the reliability of the data contained in the electronic records. Context-aware smart devices and wearable IoT devices have become increasingly common in clinical trials. Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS) do not currently address the new challenges introduced using these devices. The healthcare digital threat landscape is continually evolving, and the prevalence of sensor fusion and wearable devices compounds the growing attack surface. We propose Scrybe, a permissioned blockchain, to store proof of clinical trial data provenance. We illustrate how Scrybe addresses each control and the limitations of the Ethereum-based blockchains. Finally, we provide a proof-of-concept integration with REDCap to show tamper resistance.

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Scrybe:临床试验数据融合的安全审计跟踪。
临床试验是一个价值数十亿美元的产业。临床试验研究界面临的最大挑战之一是满足《联邦法规》第21篇第11部分[7]和ISO 27789[40]的要求。这些控制提供了审计要求,以保证电子记录中所含数据的可靠性。上下文感知智能设备和可穿戴物联网设备在临床试验中越来越普遍。电子数据采集(EDC)和临床数据管理系统(CDMS)目前没有解决使用这些设备带来的新挑战。医疗保健数字威胁格局正在不断演变,传感器融合和可穿戴设备的普及加剧了日益增长的攻击面。我们建议使用Scrybe,一种经过许可的区块链来存储临床试验数据来源的证明。我们展示了Scrybe如何解决基于以太坊的区块链的每个控制和限制。最后,我们提供了与REDCap的概念验证集成,以显示其抗篡改性。
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Scrybe: A Secure Audit Trail for Clinical Trial Data Fusion.
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