mindsON RBQM | Episode 31: Actioning Risk Signals, determining what is an issue and requirements for follow up

Understanding Signals vs. Issues in RBQM: Responding with the Right Action at the Right Time

One of the most critical aspects of Risk-Based Quality Management (RBQM) is knowing how to distinguish between a signal and an issue and acting accordingly. Misinterpreting one for the other can lead to delayed responses or unnecessary work, ultimately affecting patient safety, data integrity, and trial timelines.

In this session, we’ll break down the essential differences between a signal and an issue, helping clinical teams make confident, timely decisions.

What You’ll Learn:

What is a Signal in RBQM?

A signal is an observation often generated by centralized or remote monitoring tools—that indicates something might be wrong. It could be a data anomaly, a deviation trend, or a sudden change in site performance. Signals don’t always point to a real problem but require human evaluation.

What is an Issue?

An issue, on the other hand, is a confirmed deviation, error, or risk that needs immediate intervention. At this stage, the problem has moved beyond observation and now requires documentation, escalation, and corrective action.

Don’t miss this opportunity to strengthen your RBQM expertise. Understanding when to act and when not to on a signal can make all the difference in maintaining patient safety and regulatory compliance. Join us to gain practical insights, real-world examples, and tools that will help you manage risks with confidence and clarity throughout your clinical trials.