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Glossary

Standard of Care

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Care delivered by a healthcare provider for a specific patient which should correspond to the care that an averagely competent physician in the same field would provide under similar circumstances.

Other glossary definitions

P

Periodic Safety Update Report (PSUR)

The PSUR provides an evaluation of the risk-benefit balance of a medicinal product defined time…

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e

eTMF/ TMF: electronic Trial Master File / Trial Master File

Electronic or paper filing system which must contains all study documents and at least essential…

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