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KRI and QTL: distinguish the question before the threshold

Distinguishing operational signals from trial-level acceptable ranges makes review and response clearer.

OrioNex · Last reviewed 2026-10-20

Clarify different purposes.

A KRI can be designed to monitor an organisation’s chosen risk signals. QTLs are an example of pre-specified acceptable ranges at trial level to support control of risks to critical quality factors. Distinguish purpose and level of application before comparing names or thresholds.

A crossing starts an interpretation.

Where relevant, ICH E6(R3) describes pre-specified acceptable ranges supporting control of risks to CtQ factors. A deviation should trigger evaluation of potential systemic issues and whether action is needed. Threshold crossing and the assessment of actual quality impact belong in a connected review process.

Consider denominators and exposure.

When comparing sites or periods, review recruitment scale, data maturity, observation time and denominators. Rankings alone can distort interpretation. These are practical considerations OrioNex recommends when designing metrics.

Specify the response as well.

Document definitions, sources, numerators, denominators, analysis populations, review intervals, threshold rationale, reviewers and response pathways. Judge suitability against the trial context and CtQ factors.

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