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Glossary

Potential risk

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An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this association has not been confirmed.

Other glossary definitions

S

Significant risk device

An investigational device that:  Is intended as an implant and presents a potential for serious…

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E

End of Trial (EoT) Declaration

Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical…

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