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Glossary

Patient Reported Outcome (PRO)

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A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. A PRO can be measured by self-report or by interview provided that the interviewer records only the patient’s response.

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E

EUDAMED

The European database for medical devices EUDAMED is to centralize:  Data relating to registration of…

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S

Serious (Public) Health Threat

Any event type, which results in an imminent risk to the study population of death,…

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