Key Risk Indicators and What They Hide

Part of Clinical Project Management (PM) Training: Risk-Based Quality Management.

About 1 minutes. Free, in your language, no account needed.

An indicator is a proxy, not the thing

A key risk indicator is a number you watch because it moves before the problem does. Query rate, data entry lag, screen failure rate, deviation counts. None of them is the risk. Each is a signal that something upstream has changed.

Treating the indicator as the thing produces a trial that manages its dashboard rather than its conduct.

The average is where the signal goes to die

Twelve sites, eleven with a two-day entry lag and one at thirty days, averages to just over four days. Four days looks fine. The thirty-day site is the finding, and the average removed it.

Always look at the distribution. The trial-level number is for reporting; the per-site distribution is for managing.

Thresholds decided in advance

A threshold agreed before the data arrives is a control. A threshold chosen after looking at the numbers is a justification.

Write down, at the start, what value triggers what action and who takes it. It stops the monthly meeting where everyone agrees a number looks high and nobody does anything.

An indicator that never fires

If a KRI has never crossed its threshold in two years, one of two things is true: the trial is exceptionally well run, or the threshold is set where nothing can reach it. The second is more common, and a threshold that cannot fire is worse than no indicator, because it produces reassurance.

Review the thresholds, not only the values.