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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.

Other glossary definitions

M

Medical Device (MDR definition)

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer…

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P

Potency

(For Biologics) The measure of the biological activity using a suitably quantitative biological assay, based…

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