BACKGROUND/AIMS Traditional on-site monitoring of clinical trials via frequent site visits and 100% source data verification is cost-consuming, and it still cannot guarantee data quality effectively. Depending on the types and designs of clinical trials, an alternative would be combining several monitoring methods, such as risk-based monitoring and remote monitoring. However, there is insufficient evidence of its effectiveness. This research compared the effectiveness of risk-based monitoring with a remote monitoring system with that of traditional on-site monitoring. METHODS With a cloud-based remote monitoring system called beagle View®, we created a remote risk-based monitoring methodology that focused only on critical data and processes. We selected a randomized controlled trial conducted at Tohoku University Hospital and randomly sampled 11 subjects whose case report forms had already been reviewed by data managers. Critical data and processes were verified retrospectively by remote risk-based monitoring; later, all data and processes were confirmed by on-site monitoring. We compared the ability of remote risk-based monitoring to detect critical data and process errors with that of on-site monitoring with 100% source data verification, including an examination of clinical trial staff workload and potential cost savings. RESULTS Of the total data points (n = 5617), 19.7% (n = 1105, 95% confidence interval = 18.7-20.7) were identified as critical. The error rates of critical data detected by on-site monitoring, remote risk-based monitoring, and data review by data managers were 7.6% (n = 84, 95% CI = 6.2-9.3), 7.6% (n = 84, 95% confidence interval = 6.2-9.3), and 3.9% (n = 43, 95% confidence interval = 2.9-5.2), respectively. The total number of critical process errors detected by on-site monitoring was 14. Of these 14, 92.9% (n = 13, 95% confidence interval = 68.5-98.7) and 42.9% (n = 6, 95% confidence interval = 21.4-67.4) of critical process errors were detected by remote risk-based monitoring and data review by data managers, respectively. The mean time clinical trial staff spent dealing with remote risk-based monitoring was 9.9 ± 5.3 (mean ± SD) min per visit per subject. Our calculations show that remote risk-based monitoring saved between 9 and 41 on-site monitoring visits, corresponding to a cost of between US$13,500 and US$61,500 per trial site. CONCLUSION Remote risk-based monitoring was able to detect critical data and process errors as well as on-site monitoring with 100% source data verification, saving travel time and monitoring costs. Remote risk-based monitoring offers an effective alternative to traditional on-site monitoring of clinical trials.

中文翻译：

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临床试验监测有效性：基于远程风险的监测与具有 100% 源数据验证的现场监测

背景/目的 传统的临床试验现场监测，通过频繁的现场访问和100%的源数据验证，成本高昂，仍然无法有效保证数据质量。根据临床试验的类型和设计，另一种方法是结合多种监测方法，例如基于风险的监测和远程监测。然而，没有足够的证据证明其有效性。本研究将基于风险的监控与远程监控系统的有效性与传统现场监控的有效性进行了比较。方法 借助名为 beagle View® 的基于云的远程监控系统，我们创建了一种基于远程风险的监控方法，该方法仅关注关键数据和流程。我们选择了在东北大学医院进行的一项随机对照试验，并随机抽取了 11 名已由数据管理员审查过病例报告表的受试者。通过基于风险的远程监控对关键数据和流程进行追溯验证；随后，所有数据和流程均通过现场监测得到确认。我们将基于风险的远程监控检测关键数据和流程错误的能力与具有 100% 源数据验证的现场监控的能力进行了比较，包括检查临床试验人员的工作量和潜在的成本节约。结果 在总数据点 (n = 5617) 中，19.7% (n = 1105，95% 置信区间 = 18.7-20.7) 被确定为关键。现场监控、远程风险监控、数据管理人员审核发现的关键数据错误率为7。6%（n = 84，95% CI = 6.2-9.3）、7.6%（n = 84，95% 置信区间 = 6.2-9.3）和 3.9%（n = 43，95% 置信区间 = 2.9-5.2） ， 分别。现场监测检测到的关键过程错误总数为 14。在这 14 个中，92.9%（n = 13，95% 置信区间 = 68.5-98.7）和 42.9%（n = 6，95% 置信区间 = 21.4） -67.4) 的关键流程错误分别通过基于风险的远程监控和数据管理人员的数据审查检测到。临床试验人员处理远程基于风险的监测所花费的平均时间为 9.9 ± 5.3（平均值 ± SD）分钟。我们的计算表明，基于风险的远程监控节省了 9 到 41 次现场监控访问，相当于每个试验站点的成本在 13,500 美元到 61,500 美元之间。结论 基于远程风险的监控能够检测关键数据和流程错误以及通过 100% 源数据验证的现场监控，从而节省了旅行时间和监控成本。基于远程风险的监测为传统的临床试验现场监测提供了一种有效的替代方案。