斯克里布:临床试验数据融合的安全审计轨道
Jonathan Oakley1, Carl Worley1, L U Yu1
1Clemson University, USA.
概括
Scrybe是一个新的许可区块链,通过解决现代智能设备带来的监管合规挑战,提高了临床试验数据的完整性. 这个解决方案确保了可靠的电子记录和抗改的临床研究.
科学领域:
- 计算机科学 计算机科学
- 生物医学信息学 生物医学信息学
- 网络安全 网络安全
背景情况:
- 临床试验面临的重大挑战是满足监管要求,如21 CFR第11部分和ISO 27789.
- 越来越多的智能和可穿戴物联网设备在试验中的使用扩大了攻击面,并使数据管理复杂化.
- 现有的电子数据采集 (EDC) 和临床数据管理系统 (CDMS) 无法处理这些新数据源.
研究的目的:
- 提出Scrybe,一个允许的区块链解决方案,用于存储临床试验数据来源的证明.
- 为了展示Scrybe如何解决电子记录的监管控制问题.
- 为了评估基于以太坊的区块链对此应用的局限性.
主要方法:
- 开发Scrybe,一个许可区块链架构.
- 对Scrybe与21 CFR第11部分和ISO 27789控制器的调整进行分析.
- Scrybe与REDCap (研究电子数据捕获) 的概念验证集成.
主要成果:
- Scrybe提供了一种强大的机制,以确保临床试验数据的来源和防改.
- 拟议的区块链解决了电子记录的关键审计要求,特别是新数据源.
- 一个概念验证证明了与REDCap.Cap成功集成和改数据存储的成功.
结论:
- 在使用现代设备的临床试验中,Scrybe提供了一种可行的解决方案,以提高数据完整性和监管合规性.
- 区块链技术可以有效地保护和验证研究环境中的电子健康记录.
- 对临床试验数据管理的区块链应用进行进一步的研究是有必要的.
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