Glossary

Uncertainty

A lack of knowledge about a hazard, the harm, and the associated risk, arising from incomplete knowledge and from process variability.

Source · ICH Q9(R1) (2022), §§4.3, 5.1

Details

Uncertainty determines the confidence limits of a risk assessment and the formality and further investigation required. Inspections take issue with assessments expressed as a single definitive score without disclosing data gaps, assumptions, or variability. Look at the risk question, the assumptions and data sources, sensitivity and scenario analysis, and the plans for obtaining knowledge and for review.

Related sections

ICH Q9(R1) §§4.3, 5.1

Related terms

Knowledge ManagementFormality in Quality Risk ManagementRisk Assessment65 cases

Real inspection findings

See 1 findings whose text contains this term

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.

Source

ICH Q9(R1) (2022), §§4.3, 5.1

GRM Regulatory Glossary

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