The recently emerged risk-based monitoring (RBM) and quality tolerance limit (QTL) framework offers a more efficient alternative solution to traditional SDV (source data verification) based quality assurance. These frameworks aim at proactively identifying systematic issues that impact patient safety and data integrity.

The recently emerged risk-based monitoring (RBM) and quality tolerance limit (QTL) framework offers a more efficient alternative solution to traditional SDV (source data verification) based quality assurance. These frameworks aim at proactively identifying systematic issues that impact patient safety and data integrity.

RBM is an important component of a larger framework known as risk-based quality management (RBQM), defined in a 2013 European Medicines Agency (EMA) reflection paper as “a systematic process put in place to identify, assess, control, communicate and review the risks associated with the clinical trial during its lifecycle” [1–3].

2021年9月29日 · 从 2016 年 ICH E6R2 （章节5.0） 发布了关于基于风险的监查 （RBM Risk-Based Monitoring） 的需求以来，FDA 在不断完善 RBM 策略。 而 2020 年起，中国也开始全面实施 ICH 原则，并发布了新版 GCP （第31条） ，其中均明确提出采用系统的、基于风险的方式对临床试验进行监查。

2020年4月26日，国家药监局与国家卫健委联合发布的新版《 药物临床试验质量管理规范 》中，与时俱进地把握了 临床试验监查 数字化转型方向，提出基于风险的监查（Risk-based Monitoring, RBM）和 中心化监查 （Centralized Monitoring）模式。相较于现场监查和非现场监查 ...

2024年12月5日 · The critical issue in RBM is how to efficiently position QTL and SL thresholds and align them with risk assessment and mitigation costs. Early warning systems, which aim to inform about risks and mitigate them before they occur, are used in many industries.

Risk-based monitoring (RBM)—and its more expansive successor, risk-based quality management (RBQM)—offer a compelling approach to drive efficiency, speed and quality by prioritizing, preventing and mitigating clinical trial risks …

Quality Tolerance Limits (QTL) are statistical tools used in pharmaceutical industries to ensure quality in clinical trials. Generate figures supporting the publication of the RBM-QTL white paper. Early exploratory analysis. Figures selected based on author feedback. Figures updated based on reviewer feedback.

The simulation model aims to efficiently position each risk's QTL/KRI (Quality Tolerance Limits/Key Risk Indicators at a clinical trial level) and Secondary Limit thresholds. A case study illustrates the proposed technique's practical application and effectiveness.

To download all of TransCelerate’s solutions regarding Quality Tolerance Limits, please visit its solutions page. To download TransCelerate’s report on benchmarking RBM practices pre-COVID-19, please visit the Modernizing Clinical Trial Conduct page. As of January 2021, the Risk Based Monitoring Initiative is completed.