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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

I

Investigational New Drug (IND)

Administering an investigational drug to humans is subject to prior approval from regulatory authorities. Investigational…

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E

European Directorate for the Quality of Medicines (EDQM)

The quality of medicines and healthcare products in Europe is harmonized through different initiatives under…

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