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Glossary

Lay Person Summary (of a clinical trial)

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The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of clinical trials in a format understandable to laypersons. These lay person summaries will be made available in the EU Portal and Database.

Other glossary definitions

B

Bacteriophages (phages)

Bacteriophages (phages) are viruses that infect bacteria and depend on their bacterial host for replication.…

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I

Investigational Medicinal Product Dossier (IMPD)

Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the…

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