Glossary

Residual Risk

The risk that remains after risk controls have been applied.

Source · ICH Q9(R1) (2022), §§4.4, 5.2

Details

Residual risk must be reassessed after the control measures so that acceptability, further controls, communication, and the review interval can be decided. Inspections cite records that keep only the initial risk score, without the post-control risk, any newly created risk, or the authority for acceptance. Check the assessments before and after control, the effectiveness data, the acceptance criteria and approval, and monitoring and review records.

Related sections

ICH Q9(R1) §§4.4, 5.2

Related terms

Risk ControlRisk AcceptanceRisk Review

Source

ICH Q9(R1) (2022), §§4.4, 5.2

GRM Regulatory Glossary

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