Glossary

For CTIMPs: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator's brochure for an unauthorised investigational product or summary of product characteristics (SmPC) for an authorised product).

An appropriate measure required to be taken in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety.

Please refer to the Urgent Safety Measures station for more information.