KRI Overload: When More Isn’t Better

Key risk indicators (KRIs) are central to risk-based quality management, enabling supervised early detection of data anomalies and risks. Yet many sponsors and contract research organizations fall into the trap of creating ever-growing lists, believing more indicators yield better oversight. The ICH E6(R3) guideline for good clinical practice, however, emphasizes proportionate monitoring—and KRI overload runs counter to this principle.

In an analysis of 934 CluePoints studies, we observed a median of 18 KRIs per study. Those with <15 KRIs produced a median of 51 signals, nearly 48% of which were true issues. By contrast, studies with 40+ KRIs generated 302 signals, but only 28% were true issues (see Figure 1).

More signals don't always mean better detection. To maximize impact, KRI frameworks should follow a few guiding principles, including:

• Prioritize critical KRIs (linked to study objectives, safety, and critical data).
• Use the study risk assessment to focus KRIs on critical study risk oversight.
• Keep it manageable (15-19 well-chosen KRIs for clear oversight).
• Eliminate weak KRIs (bringing low value or false positives).
• Set clear thresholds and review regularly (ensure KRIs remain actionable and relevant at milestones).

KRIs are powerful only when they remain focused. Lean, well-selected KRIs sharpen oversight, accelerate action, and align with ICH E6(R3)’s call for proportionate, risk-based quality management.

Sylviane de Viron is Data and Knowledge Manager, Melissa Thomas is Central Monitor Consultant, and Frédéric Blais, PhD, is Director, Central Monitoring; all with CluePoints