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Glossary

Innovative Medicine

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A medicine that contains an active substance or combination of active substances that has not been authorised before.

Other glossary definitions

R

Real World Study (RWS)

Studies investigating health interventions whose design does not follow the design of a highly-controlled RCT…

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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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