Nov 5, 2024 · This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination...

Effective implementation of risk-based monitoring, including the prioritization of monitoring and other oversight activities directed at processes and procedures critical for human...

Apr 12, 2023 · This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing …

Risk-based monitoring (RBM) of clinical trials has emerged as a more targeted, strategic approach that takes advantage of increased connectivity and advances in data analytics. RBM streamlines and optimizes error detection, which may facilitate replacement of some or all on-site monitoring visits.

Recent developments—including new regulatory requirements, emerging technologies, and trial decentralization—have increased adoption of risk-based monitoring (RBM) and its parent framework, risk-based quality management (RBQM) in clinical trials.

As stated in the RBM Guidance from 2013, “risk-based monitoring, including the appropriate use of centralized monitoring [...] and reliance on technological advances (e.g., e-mail, webcasts, online training modules), can meet statutory and regulatory requirements under …

Jul 1, 2018 · Our methodology is centered on the three cornerstones of a risk-based approach to monitoring clinical trials: quality by design, central monitoring, and triggered, adaptive on-site and remote monitoring.

The purpose of risk-based monitoring is to help clinical research organizations predict and manage risk at an early stage, so that monitoring resources can be prioritized based on risk and need rather than the traditional 100% SDV approach.

Apr 13, 2023 · Introducing the game-changer in clinical investigations: The FDA has just released their highly anticipated guidance document on A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry in April 2023.

Enhancement of statistical assessment techniques enabled identification of trends, risks, and outliers early on. This led to thinking of exploring effective, alternate methods of oversight. The US FDA, in their guidance document, proposed one such approach risk-based monitoring (RBM). [1]