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Glossary

Serious (Public) Health Threat

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Any event type, which results in an imminent risk to the study population of death, serious injury, or serious illness that requires prompt remedial action and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time. 

Other glossary definitions

T

Target Product Profile (TPP)

Target product profile (TPP) in the US A TPP can be prepared by a sponsor…

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C

Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure…

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