Glossary
Risk-Based Decision-Making
Deciding how to control, accept, communicate, and review on the basis of risk together with knowledge and uncertainty.
Source · ICH Q9(R1) (2022), §§5.2 and 7 Definitions
Details
Risk-based decision-making sets the effort, the formality, and the level of documentation to match the importance, uncertainty, and complexity of the matter. Inspections may cite scores fitted to a conclusion decided in advance, or decisions made without considering data integrity, residual risk, or the evidence against. Look at the decision criteria, the supporting data, the comparison of alternatives, approval and communication, and the subsequent review.
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Real inspection findings
See 1 findings whose text contains this termCounted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q9(R1) (2022), §§5.2 and 7 DefinitionsGRM Regulatory Glossary
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